[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07544680":3,"trial-entities:NCT07544680":164,"trial-summary:NCT07544680":170},{"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":24,"study_type":34,"primary_purpose":17,"phases":35,"enrollment_info":36,"interventions":39,"primary_outcomes":40,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":58,"std_ages":82,"locations":85,"central_contacts":156,"overall_officials":161,"references":162,"see_also_links":163},"NCT07544680","2024-01","Endometrial Cancer Vaginal Fluid Specimen Collection Study","Endometrial Cancer Vaginal Fluid Specimen Collection Study: \"ENVISION\"","RECRUITING","2028-04-24","2026-07","2026-08-27","2026-03-10","Exact Sciences Corporation","INDUSTRY",false,"This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.",null,[19,20,21,22,23],"Abnormal Uterine Bleeding (AUB)","Endometrial Cancer","Atypical Endometrial Hyperplasia","Endometrial Hyperplasia With Atypia","Endometrial Intraepithelial Neoplasia",[19,25,26,27,28,29,30,31,32,33],"Endometrial Cancer (EC)","Atypical Endometrial Hyperplasia (AEH)","Endometrial Hyperplasia with Atypia","Endometrial Intraepithelial Neoplasia (EIN)","Precancerous Conditions","Post-Menopausal Bleeding","Specimen Collection","Sample Collection","in vitro diagnostic (IVD) devices","OBSERVATIONAL",[],{"count":37,"type":38},4200,"ESTIMATED",[],[41,45,49,52],{"measure":42,"description":43,"timeFrame":44},"Collection of clinically characterized vaginal fluid specimens","Vaginal fluid specimens will be collected during a standard clinical exam using a swab-based collection method. Specimens will be used for research purposes to support the development of biomarker assays. No specific biomarkers or analytical methods are defined as part of this study.","Within 90 days of enrollment.",{"measure":46,"description":47,"timeFrame":48},"Clinical data for biomarker assay development and evaluation","Clinical information will be collected as part of routine study participation and used to describe the study population and support research analyses. Data will be used in aggregate to contextualize research findings and inform future assay development.","Within 90 days of enrollment",{"measure":50,"description":51,"timeFrame":48},"Collection devices for detection","Specimens will be collected using swab-based collection devices intended solely for specimen collection. These devices do not provide diagnostic results and are not used for clinical decision-making.",{"measure":53,"description":54,"timeFrame":48},"Characterization of endometrial neoplasia, other neoplasms, or underlying causes","Characterization will be based on existing clinical assessments and diagnoses obtained through standard medical care. The study does not establish diagnostic criteria or endpoints and is intended for research and development purposes only.",[],"FEMALE","18 Years",{"inclusion":59,"exclusion":66,"raw_text":81},[60,61,62,63,64,65],"Age ≥ 45 years, OR age ≥ 18 years with at least one risk factor","Diagnosed with abnormal uterine bleeding (AUB)","Planning standard-of-care endometrial tissue sampling to assess for endometrial cancer (EC) or atypical endometrial hyperplasia\u002Fendometrial intraepithelial neoplasia (AEH\u002FEIN)","Age ≥ 18 years","Newly diagnosed, biopsy-confirmed EC or AEH\u002FEIN","Planning initial management for their endometrial pathology",[67,68,69,70,71,72,73,74,75,76,77,78,79,80],"Prior partial or complete hysterectomy","Current pregnancy","Prior pelvic or vaginal radiotherapy","Chemotherapy within past 5 years (except tamoxifen)","Any condition judged by the Investigator to preclude participation","Cancer diagnosis within past 5 years (except non-gynecologic skin cancer)","Current biopsy-proven cervical, vaginal, or vulvar cancer, or lower genital tract dysplasia","Current biopsy-proven endometrial cancer, hyperplasia, or benign polyp","Benign endometrial biopsy within last month","Cancer diagnosis other than EC within past 5 years (except non-gynecologic skin cancer)","Prior cervical cancer or biopsy-proven cervical dysplasia","Surgery for recurrent EC","Preoperative neoadjuvant chemotherapy or radiotherapy for current EC","Prior treatment or surgery to remove target pathology during current episode","Inclusion Criteria\n\nCohort 1 Participants:\n\n* Age ≥ 45 years, OR age ≥ 18 years with at least one risk factor\n* Diagnosed with abnormal uterine bleeding (AUB)\n* Planning standard-of-care endometrial tissue sampling to assess for endometrial cancer (EC) or atypical endometrial hyperplasia\u002Fendometrial intraepithelial neoplasia (AEH\u002FEIN)\n\nCohort 2 Participants:\n\n* Age ≥ 18 years\n* Newly diagnosed, biopsy-confirmed EC or AEH\u002FEIN\n* Planning initial management for their endometrial pathology\n\nExclusion Criteria\n\n* Prior partial or complete hysterectomy\n* Current pregnancy\n* Prior pelvic or vaginal radiotherapy\n* Chemotherapy within past 5 years (except tamoxifen)\n* Any condition judged by the Investigator to preclude participation\n\nAdditional for Cohort 1:\n\n* Cancer diagnosis within past 5 years (except non-gynecologic skin cancer)\n* Current biopsy-proven cervical, vaginal, or vulvar cancer, or lower genital tract dysplasia\n* Current biopsy-proven endometrial cancer, hyperplasia, or benign polyp\n* Benign endometrial biopsy within last month\n\nAdditional for Cohort 2:\n\n* Cancer diagnosis other than EC within past 5 years (except non-gynecologic skin cancer)\n* Prior cervical cancer or biopsy-proven cervical dysplasia\n* Surgery for recurrent EC\n* Preoperative neoadjuvant chemotherapy or radiotherapy for current EC\n* Prior treatment or surgery to remove target pathology during current episode",[83,84],"ADULT","OLDER_ADULT",[86,104,119,134,141],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":101},"Physical Care Clinical Research","Sarasota","Florida","34249","United States",[93,98],{"name":94,"role":95,"phone":96,"email":97},"Research Coordinator","CONTACT","941-954-2355","JAranda@PCCRSarasota.com",{"name":99,"role":100},"Gregory Michael Swor, MD","PRINCIPAL_INVESTIGATOR",{"lat":102,"lon":103},27.33643,-82.53065,{"facility":105,"status":8,"city":106,"state":107,"zip":108,"country":91,"contacts":109,"geoPoint":116},"MaineHealth","Scarborough","Maine","04070",[110,114],{"name":111,"role":95,"phone":112,"email":113},"Study Coordinator","207-606-7347","ntro@mainehealth.org",{"name":115,"role":100},"Leslie Bradford, MD",{"lat":117,"lon":118},43.57814,-70.32172,{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":91,"contacts":124,"geoPoint":131},"Murfreesboro Medical Clinic","Murfreesboro","Tennessee","37130",[125,129],{"name":126,"role":95,"phone":127,"email":128},"Miles Guy","615-410-3460","mguy@icresearch.net",{"name":130,"role":100},"Brad Chesney, MD",{"lat":132,"lon":133},35.84562,-86.39027,{"facility":135,"status":8,"city":121,"state":122,"zip":136,"country":91,"contacts":137,"geoPoint":140},"IC Research","37132",[138,139],{"name":126,"role":95,"phone":127,"email":128},{"name":130,"role":100},{"lat":132,"lon":133},{"facility":142,"status":8,"city":143,"state":144,"zip":145,"country":91,"contacts":146,"geoPoint":153},"National Research Center - Frisco","Frisco","Texas","75034",[147,151],{"name":148,"role":95,"phone":149,"email":150},"Virginia Chacin","786-375-6210","vchacin@nrcinc.com",{"name":152,"role":100},"Henry Ramirez, MD",{"lat":154,"lon":155},33.15067,-96.82361,[157],{"name":158,"role":95,"phone":159,"email":160},"Clinical Trial Manager","608-982-1588","ENVISION_Study_Info@exactsciences.com",[],[],[],{"nct_id":4,"conditions":165,"biomarkers":169},[166,167,168],"Abnormal uterine bleeding","Endometrial Atypical Hyperplasia\u002FEndometrioid Intraepithelial Neoplasia","Endometrial Carcinoma",[],{"nct_id":4,"found":171,"summary":172,"prompt_version":181},true,{"design":173,"status":174,"heading":6,"summary":175,"follow_up":176,"word_count":177,"commitments":178,"compensation":179,"drugs_mentioned":180},"This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 4200 participants.","completed","This study is collecting vaginal fluid samples to help develop and test new ways to detect endometrial cancer and other related conditions. Researchers are looking for women aged 18 and older who have abnormal uterine bleeding (AUB) and are already planning to have a standard procedure to check for endometrial cancer or atypical endometrial hyperplasia (pre-cancerous changes in the uterine lining). The goal is to gather enough samples and clinical information to create better detection tools. The study aims to enroll 4200 participants. The study's success will be measured by collecting these samples and related clinical data within 90 days of you joining.","Your participation involves specimen and data collection within 90 days of enrollment.",103,"You would provide vaginal fluid specimens and clinical data. This collection would happen within 90 days of joining the study.","Not stated in the trial record.",[],"v2"]