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.
- Study design
- 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.
- What's involved
- You would have a vaginal fluid sample collected using a small swab and a blood sample collected, both before any other exams or procedures.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure outcomes over 18 months to see how well the new detection methods perform.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05051722
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Recruiting
Not specifiedAges 18+ObservationalMayo ClinicInvestigator-initiated
~3,110 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:Vaginal Fluid CollectionBlood Collection
At a glance
Recruiting sites
20 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 18 months
+1 more outcome measured
Conditions
Where it's being run
24 sites across 14 statesFlorida6
Wisconsin3
Illinois2
New York2
Texas2
Arizona1
Georgia1
Louisiana1
Study leadership
- Jamie N. Bakkum-Gamez, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Abnormal uterine bleeding
Postmenopausal bleeding
Abnormal uterine 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/endocervical 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/or 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/occlusion)
Presence of clinically probable ovarian, fallopian tube, or primary peritoneal cancer (all under the umbrella of OC) based on clinical findings of any/all of the following: imaging showing adnexal and/or 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
For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\* (without prior tubal ligation/occlusion)
Exclusion
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/sampling 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 hysterectomy
Current known pregnancy diagnosis
Prior or current biopsy-proven cervical cancer
Presence of concomitant biopsy-proven cervical dysplasia
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
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
Current known pregnancy diagnosis
Cervical mass biopsy-proven to be EC or a cancer metastatic from a non-cervical origin
Any prior cancer (except basal cell skin cancer) within the past 5 years
Chemotherapy within the past 5 years
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 / 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 hysterectomy
Current known pregnancy diagnosis
Prior or current biopsy-proven gynecologic cancer
Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia
Prior pelvic or vaginal radiotherapy
Any prior cancer (except basal cell skin cancer) within the past 5 years
Chemotherapy within the past 5 years
Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis
Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode
Pap test or cervical biopsy within the past 1 month
Endometrial biopsy or office hysteroscopy within the past 1 month
Any surgery within the past 3 months
Prior hysterectomy
Current known pregnancy diagnosis
Prior or current biopsy-proven gynecologic cancer
Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia
Prior pelvic or vaginal radiotherapy
Any prior cancer (except basal cell skin cancer) within the past 5 years
Chemotherapy within the past 5 years
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
Chemotherapy for cancer treatment within the past 5 years prior to collection
History of pelvic or vaginal radiation therapy
Known current synchronous endometrial cancer or hyperplasia
Known current cervical, vaginal, or vulvar dysplasia
Current known pregnancy diagnosis
What this trial measures
- 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.18 months
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.
- 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.18 months
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.