[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05051722":3,"trial-entities:NCT05051722":500,"trial-summary:NCT05051722":510},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":51,"secondary_outcomes":59,"sex":63,"minimum_age":64,"maximum_age":27,"healthy_volunteers":15,"eligibility_criteria":65,"std_ages":125,"locations":128,"central_contacts":486,"overall_officials":492,"references":495,"see_also_links":496},"NCT05051722","20-012833","Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer","Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer: a Phase II Clinical Study","RECRUITING","2027-06-30","2026-04","2026-04-17","2021-08-03","Mayo Clinic","OTHER",false,"The overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and\u002For plasma.\n\nThis proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in vaginal fluid and 2) ovarian cancer (OC) in plasma and vaginal fluid. Additionally, it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer (CC) MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.er detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.","Detection of endometrial, ovarian, and cervical cancers at an early stage vastly increases the chances of cure and may also avert morbidity secondary to surgical staging, radiation, and\u002For chemotherapy. Despite the great successes of cervical cancer screening, comparable early detection methods for other gynecologic cancers and their precursors are not available. While nearly 1.5 million women per year in the United States are evaluated for abnormal uterine bleeding (AUB) or postmenopausal bleeding (PMB), the most common symptom of endometrial cancer, most undergo an invasive diagnostic biopsy with the finding of benign etiology.\n\nVaginal bleeding is often the only presenting symptom of women ultimately diagnosed with endometrial cancer (EC) or its precursor lesion, endometrial hyperplasia(EH). More than 90% of women with EC present with vaginal bleeding. Cervical cancer and cervical dysplasia can present as intermenstrual bleeding, post-coital bleeding, or other abnormal vaginal bleeding. However, most women who present with AUB or PMB have a benign etiology.\n\nThere are approximately 70 million women ≥45 years of age in the United States based on the most recent census data. Between 4-11% of women will be worked up for perimenopausal AUB or PMB in their lifetime. As only 5-10% of those women will have an EC or EH, there is a great clinical need for a less invasive clinical diagnostic test that can reliably distinguish between benign uterine bleeding and bleeding associated with an underlying endometrial cancer, cervical cancer, or a precursor lesion.",[19,20,21,22,23,24],"Endometrial Cancer","Cervical Cancer","Atypical Endometrial Hyperplasia","Cervical Dysplasia","Adnexal Mass","Ovarian Cancer",[],"OBSERVATIONAL",null,[],{"count":30,"type":31},3110,"ESTIMATED",[33,47],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":45},"DIAGNOSTIC_TEST","Vaginal Fluid Collection","A sample of vaginal fluid will be collected from each participant, prior to any exams or procedures, by a healthcare provider using a small vaginal swab.",[38,39,40,41,42,43,44],"Cohort 1 - AUB \u002F PMB","Cohort 2 - Biopsy-proven EC or AEH or EIN","Cohort 3 - Cervix pathology","Cohort 4 - Benign Uterine Pathology","Cohort 5 - Healthy Control Women","Cohort 6- Isolated Adnexal Mass Cohort (ovarian or fallopian mass)","Cohort 7 - OC Cohort - Biopsy proven or clinically suspected ovarian cancer (OC)",[46],"Vaginal Fluid",{"type":34,"name":48,"description":49,"armGroupLabels":50},"Blood Collection","A blood sample will be collected from each participant prior to undergoing any exams or procedures.",[38,39,40,41,42,43,44],[52,56],{"measure":53,"description":54,"timeFrame":55},"Develop predictive models from a panel of EC-specific MDMs and validate their performance in identifying underlying EC and AEH within vaginal fluid in a larger, more diverse cohort.","Complete a phase II biomarker development study of a methylated DNA marker (MDM)-based endometrial cancer detection test performed on vaginal fluid. The phase II aspect of this biomarker development study will narrow the number of endometrial cancer MDMs within the biomarker panel in order to optimize the next phase of test development.","18 months",{"measure":57,"description":58,"timeFrame":55},"Develop predictive models from a panel of OC-specific MDMs and validate their performance in identifying underlying OC within vaginal fluid and plasma in a larger, more diverse cohort.","Complete a phase II biomarker development study of a methylated DNA marker (MDM)-based ovarian cancer detection test performed on vaginal fluid. The phase II aspect of this biomarker development study will narrow the number of ovarian cancer MDMs within the biomarker panel in order to optimize the next phase of test development.",[60],{"measure":61,"description":62,"timeFrame":55},"Using 95% specificity cutoffs of the final MDM EC panel, determine the false positive rate among women undergoing surgical removal of common benign gynecologic pathology","As part of this biomarker test development, understanding whether common non-cancerous uterine or gynecologic conditions may also lead to the finding of currently apparent endometrial cancer-specific MDMs in vaginal fluid is critical in determining specificity, positive predictive value, and negative predictive value of the test.","FEMALE","18 Years",{"inclusion":66,"exclusion":87,"raw_text":124},[67,68,67,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,83],"Abnormal uterine bleeding","Postmenopausal bleeding","One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use)","Presence of biopsy-proven EC (any histology, including uterine carcinosarcoma) and surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\\&C, hysteroscopic resection","Biopsy showing AEH or EIN with surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\\&C, hysteroscopic resection, etc)","History of current abnormal cervical\u002Fendocervical Pap test for which the patient is presenting for colposcopy","Cervical mass identified on physical exam and patient referred for cervical biopsy, even if colposcopy not recommended or indicated","Planned clinically indicated surgical excisional biopsy or removal of the cervix (cold knife cone, LEEP, hysterectomy) for abnormal Pap test, cervical dysplasia, cervical mass, or biopsy-proven invasive cervical cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or less common primary cervical carcinomas all eligible)","Undergoing hysterectomy with biopsy-proven or clinically presumed (based on imaging and\u002For clinical symptoms) benign gynecologic or uterine pathology of fibroids, endometriosis, adenomyosis, or benign endometrial polyps.","Undergoing any gynecologic surgery in which a benign pathologic tissue diagnosis of fibroids, endometriosis, adenomyosis, or benign endometrial polyp is anticipated to be confirmed.","Presenting for GYN wellness exam, ± Pap test","No change in medical conditions, new diagnoses, or new medications within the past 6 months","Postmenopausal","At least 1 intact ovary","Diagnosis of an adnexal mass or a clinical suspicion of early-stage ovarian cancer (including fallopian tube cancer)","Planned surgery for the adnexal mass","For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\\* (without prior tubal ligation\u002Focclusion)","Presence of clinically probable ovarian, fallopian tube, or primary peritoneal cancer (all under the umbrella of OC) based on clinical findings of any\u002Fall of the following: imaging showing adnexal and\u002For abdominal masses consistent with probable ovarian cancer, omental caking, elevated CA125, ascites, imaging-guided biopsy consistent with OC pathology","Newly diagnosed with ovarian, fallopian tube or primary peritoneal cancer without neoadjuvant therapy","At least one intact ovary",[88,89,90,91,92,93,94,95,96,97,98,88,89,99,100,90,91,92,101,102,103,89,104,91,92,105,106,107,108,88,89,109,110,111,91,92,112,106,113,114,108,88,89,109,110,111,91,92,115,116,117,118,119,120,121,122,123,116,119,120,121,89],"Prior hysterectomy","Current known pregnancy diagnosis","Any prior pelvic or vaginal radiotherapy","Any prior cancer (except basal cell skin cancer) within the past 5 years","Chemotherapy within the past 5 years","Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia","Current biopsy-proven endometrial cancer or endometrial hyperplasia","Current biopsy-proven benign endometrial polyp","Endometrial biopsy\u002Fsampling within the preceding 1 month showing benign endometrium","Undergoing surgical procedure for recurrent or metastatic EC","Received preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis","Prior or current biopsy-proven cervical cancer","Presence of concomitant biopsy-proven cervical dysplasia","Prior intervention or surgery with intent to completely remove the target pathology","History of pelvic or vaginal radiotherapy","Prior total hysterectomy (cervix removed) for any indication","Cervical mass biopsy-proven to be EC or a cancer metastatic from a non-cervical origin","Patients presenting for colposcopy as part of lower genital tract dysplasia or cancer surveillance after prior curative intent treatment and no current Pap abnormality or cervical mass","Prior intervention or surgery with intent to completely remove the target pathology for the current lesion \u002F diagnosis during the current episode","Endometrial biopsy or office hysteroscopy within 2 weeks preceding the planned gynecologic surgery procedure for fibroids, endometriosis, benign endometrial polyps, or adenomyosis","Any surgery within the past 3 months","Prior or current biopsy-proven gynecologic cancer","Current biopsy-proven AEH\u002FEIN, cervical, vaginal, or vulvar dysplasia","Prior pelvic or vaginal radiotherapy","Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis","Pap test or cervical biopsy within the past 1 month","Endometrial biopsy or office hysteroscopy within the past 1 month","Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn)","Chemotherapy for cancer treatment within the past 5 years prior to collection","Clinically suspected advanced stage ovarian cancer (Stage III or IV) on presentation, if known prior to specimen collection","Surgical candidates for recurrent ovarian cancer","History of pelvic or vaginal radiation therapy","Known current synchronous endometrial cancer or hyperplasia","Known current cervical, vaginal, or vulvar dysplasia","Patients with recurrent OC","Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years","Inclusion Criteria for Cohort 1:\n\nPatients will be ≥45 years of age and meet one of the following criteria:\n\n* Abnormal uterine bleeding\n* Postmenopausal bleeding\n\nOR\n\nPatients ages 18 - 44 years of age and meet these criteria\n\n* Abnormal uterine bleeding\n* One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use)\n\nExclusion Criteria for Cohort 1:\n\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Any prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia\n* Current biopsy-proven endometrial cancer or endometrial hyperplasia\n* Current biopsy-proven benign endometrial polyp\n* Endometrial biopsy\u002Fsampling within the preceding 1 month showing benign endometrium\n\nInclusion Criteria for Cohort 2:\n\nPatients will be ≥18 years of age and meet at least one of the following criteria:\n\n* Presence of biopsy-proven EC (any histology, including uterine carcinosarcoma) and surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\\&C, hysteroscopic resection\n* Biopsy showing AEH or EIN with surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\\&C, hysteroscopic resection, etc)\n\nExclusion Criteria for Cohort 2:\n\n* Undergoing surgical procedure for recurrent or metastatic EC\n* Received preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Prior or current biopsy-proven cervical cancer\n* Presence of concomitant biopsy-proven cervical dysplasia\n* Any prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Prior intervention or surgery with intent to completely remove the target pathology\n\nInclusion Criteria for Cohort 3:\n\nPatients will be ≥18 years of age, have a cervix and meet at least one of the following criteria:\n\n* History of current abnormal cervical\u002Fendocervical Pap test for which the patient is presenting for colposcopy\n* Cervical mass identified on physical exam and patient referred for cervical biopsy, even if colposcopy not recommended or indicated\n* Planned clinically indicated surgical excisional biopsy or removal of the cervix (cold knife cone, LEEP, hysterectomy) for abnormal Pap test, cervical dysplasia, cervical mass, or biopsy-proven invasive cervical cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or less common primary cervical carcinomas all eligible)\n\nExclusion Criteria for Cohort 3:\n\n* History of pelvic or vaginal radiotherapy\n* Prior total hysterectomy (cervix removed) for any indication\n* Current known pregnancy diagnosis\n* Cervical mass biopsy-proven to be EC or a cancer metastatic from a non-cervical origin\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Patients presenting for colposcopy as part of lower genital tract dysplasia or cancer surveillance after prior curative intent treatment and no current Pap abnormality or cervical mass\n* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion \u002F diagnosis during the current episode\n\nInclusion Criteria for Cohort 4:\n\nPatients will be ≥45 years of age and should meet at least one of the following criteria:\n\n* Undergoing hysterectomy with biopsy-proven or clinically presumed (based on imaging and\u002For clinical symptoms) benign gynecologic or uterine pathology of fibroids, endometriosis, adenomyosis, or benign endometrial polyps.\n* Undergoing any gynecologic surgery in which a benign pathologic tissue diagnosis of fibroids, endometriosis, adenomyosis, or benign endometrial polyp is anticipated to be confirmed.\n\nExclusion Criteria for Cohort 4:\n\n* Endometrial biopsy or office hysteroscopy within 2 weeks preceding the planned gynecologic surgery procedure for fibroids, endometriosis, benign endometrial polyps, or adenomyosis\n* Any surgery within the past 3 months\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Prior or current biopsy-proven gynecologic cancer\n* Current biopsy-proven AEH\u002FEIN, cervical, vaginal, or vulvar dysplasia\n* Prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis\n* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion \u002F diagnosis during the current episode\n\nInclusion Criteria for Cohort 5:\n\nPatients with a uterus will be ≥45 years of age and should meet the following criteria:\n\n* Presenting for GYN wellness exam, ± Pap test\n* No change in medical conditions, new diagnoses, or new medications within the past 6 months\n\nExclusion Criteria for Cohort 5:\n\n* Pap test or cervical biopsy within the past 1 month\n* Endometrial biopsy or office hysteroscopy within the past 1 month\n* Any surgery within the past 3 months\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Prior or current biopsy-proven gynecologic cancer\n* Current biopsy-proven AEH\u002FEIN, cervical, vaginal, or vulvar dysplasia\n* Prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Criteria met for inclusion in any of the other study cohorts\n\nInclusion Criteria for Cohort 6:\n\nPatients ≥50 years of age and:\n\n* Postmenopausal\n* At least 1 intact ovary\n* Diagnosis of an adnexal mass or a clinical suspicion of early-stage ovarian cancer (including fallopian tube cancer)\n* Planned surgery for the adnexal mass\n* For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\\* (without prior tubal ligation\u002Focclusion)\n\nExclusion criteria for Cohort 6:\n\n* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn)\n* Chemotherapy for cancer treatment within the past 5 years prior to collection\n* Clinically suspected advanced stage ovarian cancer (Stage III or IV) on presentation, if known prior to specimen collection\n* Surgical candidates for recurrent ovarian cancer\n* History of pelvic or vaginal radiation therapy\n* Known current synchronous endometrial cancer or hyperplasia\n* Known current cervical, vaginal, or vulvar dysplasia\n\nInclusion criteria for Cohort 7:\n\nWomen will be ≥18 years of age and meet the following criteria:\n\n* Presence of clinically probable ovarian, fallopian tube, or primary peritoneal cancer (all under the umbrella of OC) based on clinical findings of any\u002Fall of the following: imaging showing adnexal and\u002For abdominal masses consistent with probable ovarian cancer, omental caking, elevated CA125, ascites, imaging-guided biopsy consistent with OC pathology\n* Newly diagnosed with ovarian, fallopian tube or primary peritoneal cancer without neoadjuvant therapy\n* At least one intact ovary\n* For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\\* (without prior tubal ligation\u002Focclusion)\n\nExclusion criteria for Cohort 7:\n\n* Patients with recurrent OC\n* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years\n* Chemotherapy for cancer treatment within the past 5 years prior to collection\n* History of pelvic or vaginal radiation therapy\n* Known current synchronous endometrial cancer or hyperplasia\n* Known current cervical, vaginal, or vulvar dysplasia\n* Current known pregnancy diagnosis",[126,127],"ADULT","OLDER_ADULT",[129,146,160,168,182,199,206,224,239,256,263,282,297,311,330,345,354,373,390,405,423,442,461,479],{"facility":13,"status":8,"city":130,"state":131,"zip":132,"country":133,"contacts":134,"geoPoint":143},"Phoenix","Arizona","85054","United States",[135,140],{"name":136,"role":137,"phone":138,"email":139},"Favy Trujillo","CONTACT","480-574-1468","trujillo.faviola@mayo.edy",{"name":141,"role":142},"Kristina A. Butler, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":144,"lon":145},33.44838,-112.07404,{"facility":13,"status":8,"city":147,"state":148,"zip":149,"country":133,"contacts":150,"geoPoint":157},"Jacksonville","Florida","32224",[151,155],{"name":152,"role":137,"phone":153,"email":154},"Ashley N Shelton, CRC","504-953-1594","Shelton.Ashley@mayo.edu",{"name":156,"role":142},"Tri A. Dinh, M.D.",{"lat":158,"lon":159},30.33218,-81.65565,{"facility":161,"status":162,"city":163,"state":148,"zip":164,"country":133,"geoPoint":165},"My GYN Care","ACTIVE_NOT_RECRUITING","Miami","33156",{"lat":166,"lon":167},25.77427,-80.19366,{"facility":169,"status":8,"city":163,"state":148,"zip":170,"country":133,"contacts":171,"geoPoint":181},"Genoma Research, Inc.","33173",[172,176,178],{"name":173,"role":137,"phone":174,"email":175},"Laura Lucia, BHSc, CRC","305-392-1264","lauralucia@genoma.comcastbiz.net",{"name":177,"role":142},"Guillermo Lievano, D.O.",{"name":179,"role":180},"Itsel Cardenas, PhD, APRN","SUB_INVESTIGATOR",{"lat":166,"lon":167},{"facility":183,"status":8,"city":184,"state":148,"zip":185,"country":133,"contacts":186,"geoPoint":196},"Orlando Health","Orlando","32806",[187,191,194],{"name":188,"role":137,"phone":189,"email":190},"Donya Shahnavaz, CRC","321-841-7303","donya.shahnavaz@orlandohealth.com",{"name":192,"role":137,"email":193},"Bianca Henry, CRC","bianca.henry@orlandohealth.com",{"name":195,"role":142},"Shelly M. Seward, M.D.",{"lat":197,"lon":198},28.53834,-81.37924,{"facility":200,"status":162,"city":201,"state":148,"zip":202,"country":133,"geoPoint":203},"Signature Women's Healthcare, LLC","Pembroke Pines","33029",{"lat":204,"lon":205},26.00315,-80.22394,{"facility":207,"status":8,"city":208,"state":148,"zip":209,"country":133,"contacts":210,"geoPoint":221},"Sarasota Memorial Health Care System","Sarasota","34239",[211,214,217,219],{"name":212,"role":137,"email":213},"Rachael Sanacore","Rachael-Sanacore@smh.com",{"name":215,"role":137,"email":216},"Megan Swiger","Megan-Swiger@smh.com",{"name":218,"role":142},"Toni P Kilts, D.O.",{"name":220,"role":180},"Beverly J Long, M.D.",{"lat":222,"lon":223},27.33643,-82.53065,{"facility":225,"status":8,"city":226,"state":227,"zip":228,"country":133,"contacts":229,"geoPoint":236},"Piedmont Healthcare","Atlanta","Georgia","30318",[230,234],{"name":231,"role":137,"phone":232,"email":233},"Dionne Jean, CRC","404-425-7927","dionne.jean@piedmont.org",{"name":235,"role":142},"Leda Portia A. Gattoc, M.D.",{"lat":237,"lon":238},33.749,-84.38798,{"facility":240,"status":8,"city":241,"state":242,"zip":243,"country":133,"contacts":244,"geoPoint":253},"University of Chicago","Chicago","Illinois","60637",[245,248,251],{"name":246,"role":137,"email":247},"Calla O'Connor, MPH","calla.oconnor@bsd.uchicago.edu",{"name":249,"role":137,"email":250},"Veronika Sesari","vseseri@bsd.uchicago.edu",{"name":252,"role":142},"Kathryn Mills, M.D.",{"lat":254,"lon":255},41.85003,-87.65005,{"facility":257,"status":162,"city":258,"state":242,"zip":259,"country":133,"geoPoint":260},"Providea Health Partners, LLC","Evergreen Park","60805",{"lat":261,"lon":262},41.72059,-87.70172,{"facility":264,"status":8,"city":265,"state":266,"zip":267,"country":133,"contacts":268,"geoPoint":279},"Ochsner Clinic Foundation","New Orleans","Louisiana","70121",[269,273,277],{"name":270,"role":137,"phone":271,"email":272},"Ashley Samuel, CRC","504-703-2658","ashley.samuel@ochsner.org",{"name":274,"role":137,"phone":275,"email":276},"Veronica Hixon Calliet, BSN","504-703-8602","veronica.hixoncalliet@ochsner.org",{"name":278,"role":142},"Diogo Torres, M.D.",{"lat":280,"lon":281},29.95465,-90.07507,{"facility":283,"status":8,"city":284,"state":285,"zip":286,"country":133,"contacts":287,"geoPoint":294},"Valley OB-GYN Clinic","Saginaw","Michigan","48602",[288,292],{"name":289,"role":137,"phone":290,"email":291},"Jacqueline Lang, CCRC","989-272-9065","jacqueline.lang@elligodirect.com",{"name":293,"role":142},"Olivia A. Phifer-Combs, M.D.",{"lat":295,"lon":296},43.41947,-83.95081,{"facility":13,"status":8,"city":298,"state":299,"zip":300,"country":133,"contacts":301,"geoPoint":308},"Rochester","Minnesota","55905",[302,306],{"name":303,"role":137,"phone":304,"email":305},"Maureen A Lemens, BSN","507-293-1487","lemens.maureen@mayo.edu",{"name":307,"role":142},"Jamie N. Bakkum-Gamez, MD",{"lat":309,"lon":310},44.02163,-92.4699,{"facility":312,"status":8,"city":313,"state":314,"zip":315,"country":133,"contacts":316,"geoPoint":327},"University of Mississippi Medical Center","Jackson","Mississippi","39213",[317,321,325],{"name":318,"role":137,"phone":319,"email":320},"Adriana Dodson, RN","601-984-1962","adodson2@umc.edu",{"name":322,"role":137,"phone":323,"email":324},"Kenna H Nettles, PA-C","601-815-5963","knettles1@umc.edu",{"name":326,"role":142},"Rodney Rocconi, M.D.",{"lat":328,"lon":329},32.29876,-90.18481,{"facility":331,"status":8,"city":332,"state":333,"zip":334,"country":133,"contacts":335,"geoPoint":342},"The Woman's Health Pavilion","Howard Beach","New York","11414",[336,340],{"name":337,"role":137,"phone":338,"email":339},"Monica Martinez, CRC","718-843-6300","mmartinez@ilovemygyn.com",{"name":341,"role":142},"Andre H. Saad, M.D.",{"lat":343,"lon":344},40.65788,-73.83625,{"facility":331,"status":8,"city":346,"state":333,"zip":347,"country":133,"contacts":348,"geoPoint":351},"Westbury","11590",[349,350],{"name":337,"role":137,"phone":338,"email":339},{"name":341,"role":142},{"lat":352,"lon":353},40.75566,-73.58763,{"facility":355,"status":8,"city":356,"state":357,"zip":358,"country":133,"contacts":359,"geoPoint":370},"Altru Health System","Grand Forks","North Dakota","58206",[360,364,368],{"name":361,"role":137,"phone":362,"email":363},"Alexis Tatum, CRC","701-780-1563","atatum@altru.org",{"name":365,"role":137,"phone":366,"email":367},"Tina Schmitz, BSN","701-780-1845","tkschmitz@altru.org",{"name":369,"role":142},"Collette Lessard, M.D.",{"lat":371,"lon":372},47.92526,-97.03285,{"facility":374,"status":8,"city":375,"state":376,"zip":377,"country":133,"contacts":378,"geoPoint":387},"Cleveland Clinic","Cleveland","Ohio","44195",[379,382,385],{"name":380,"role":137,"email":381},"Tori Carpenter, CRC","carpent3@ccf.org",{"name":383,"role":137,"email":384},"Sarah Neale, CRC","neales@ccf.org",{"name":386,"role":142},"Michelle L. Kuznicki, M.D.",{"lat":388,"lon":389},41.4995,-81.69541,{"facility":391,"status":8,"city":392,"state":393,"zip":394,"country":133,"contacts":395,"geoPoint":402},"Total Women's Care of the Heights","Houston","Texas","77018",[396,400],{"name":397,"role":137,"phone":398,"email":399},"Tatiana Rivera","346-330-5302","ma@twcheights.com",{"name":401,"role":142},"Vonne Jones, M.D.",{"lat":403,"lon":404},29.76328,-95.36327,{"facility":406,"status":8,"city":407,"state":393,"zip":408,"country":133,"contacts":409,"geoPoint":420},"Medical Colleagues of Texas, LLP","Katy","77450",[410,414,418],{"name":411,"role":137,"phone":412,"email":413},"Erika Keller, CRC","281-769-8674","erika.keller@elligodirect.com",{"name":415,"role":137,"phone":416,"email":417},"Gabriella Coletta, CRC","512-351-4565","gabiella.coletta@elligodirect.com",{"name":419,"role":142},"Kelly A. McCullagh, M.D.",{"lat":421,"lon":422},29.78579,-95.8244,{"facility":424,"status":8,"city":425,"state":426,"zip":427,"country":133,"contacts":428,"geoPoint":439},"Virginia Commonwealth University\u002F Massey Cancer Center","Richmond","Virginia","23219",[429,433,437],{"name":430,"role":137,"phone":431,"email":432},"Morgan DeHart","804-827-1266","dehart2@vcu.edu",{"name":434,"role":137,"phone":435,"email":436},"Faith McFadden, MSN","804-628-0616","mcfaddenfr@vcu.edu",{"name":438,"role":142},"Chelsea Salyer, M.D.",{"lat":440,"lon":441},37.55376,-77.46026,{"facility":443,"status":8,"city":444,"state":445,"zip":446,"country":133,"contacts":447,"geoPoint":458},"Mayo Clinic Health System - Northwest Wisconsin","Eau Claire","Wisconsin","54703",[448,452,456],{"name":449,"role":137,"phone":450,"email":451},"Stephanie L Larson, ACRC","715-838-1976","larson.stephanie3@mayo.edu",{"name":453,"role":137,"phone":454,"email":455},"Christina M Scinto, ACRC","715-464-8172","cinto.christina@mayo.edu",{"name":457,"role":142},"Blenda Yun, M.D.",{"lat":459,"lon":460},44.81135,-91.49849,{"facility":462,"status":8,"city":463,"state":445,"zip":464,"country":133,"contacts":465,"geoPoint":476},"Mayo Clinic Health System - Southwest Wisconsin","La Crosse","54601",[466,470,474],{"name":467,"role":137,"phone":468,"email":469},"Kate L Zboralski, ACRC","608-392-9521","zboralski.kathryn@mayo.edu",{"name":471,"role":137,"phone":472,"email":473},"Taylor Cammer, ACRC","608-392-9280","cammer.taylor@mayo.edu",{"name":475,"role":142},"Rebecca A. Scarseth, D.O.",{"lat":477,"lon":478},43.80136,-91.23958,{"facility":480,"status":162,"city":481,"state":445,"zip":482,"country":133,"geoPoint":483},"Medical College of Wisconsin","Milwaukee","53226",{"lat":484,"lon":485},43.0389,-87.90647,[487,488],{"name":303,"role":137,"phone":304,"email":305},{"name":489,"role":137,"phone":490,"email":491},"Clinical Trials Referral Office","855-776-0015","mayocliniccancerstudies@mayo.edu",[493],{"name":494,"affiliation":13,"role":142},"Jamie N. Bakkum-Gamez, M.D.",[],[497],{"label":498,"url":499},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":501,"biomarkers":509},[23,502,503,504,505,506,507,508],"Cervical Carcinoma","Cervical Intraepithelial Neoplasia","Endometrial Atypical Hyperplasia\u002FEndometrioid Intraepithelial Neoplasia","Endometrial Carcinoma","Fallopian Tube Carcinoma","Malignant Ovarian Neoplasm","Primary Peritoneal Cancer",[],{"nct_id":4,"found":511,"summary":512,"prompt_version":522},true,{"design":513,"status":514,"heading":515,"summary":516,"follow_up":517,"word_count":518,"commitments":519,"compensation":520,"drugs_mentioned":521},"This is an observational study planning to enroll 3110 women. It is not testing a new treatment, but rather looking for ways to improve cancer detection.","completed","Observational Study for Gynecologic Cancer Detection","This study aims to develop new ways to detect endometrial, ovarian, and cervical cancers early. Researchers are looking for specific markers called methylated DNA markers (MDMs) and high-risk human papillomavirus (HR-HPV) in vaginal fluid and blood samples. The goal is to create better tests for these cancers and their precursors, like atypical endometrial hyperplasia (AEH) and cervical dysplasia. You might be able to join if you are a woman aged 18 or older with abnormal uterine bleeding, or if you are 45 or older with postmenopausal bleeding. The study will measure how well these new tests can identify cancer over 18 months. The current status of this study is unclear.","The study will measure outcomes over 18 months to see how well the new detection methods perform.",110,"You would have a vaginal fluid sample collected using a small swab and a blood sample collected, both before any other exams or procedures.","Not stated in the trial record.",[],"v2"]