Endometrial Cancer Vaginal Fluid Specimen Collection Study (NCT07544680) | Clinical Trial Compass
RecruitingNot Applicable
Endometrial Cancer Vaginal Fluid Specimen Collection Study
United States4,200 participantsStarted 2026-03-10
Plain-language summary
This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Cohort 1 Participants:
* 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/endometrial intraepithelial neoplasia (AEH/EIN)
Cohort 2 Participants:
* Age ≥ 18 years
* Newly diagnosed, biopsy-confirmed EC or AEH/EIN
* Planning initial management for their endometrial pathology
Exclusion Criteria
* 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
Additional for Cohort 1:
* 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
Additional for Cohort 2:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Collection of clinically characterized vaginal fluid specimens
Timeframe: Within 90 days of enrollment.
2
Clinical data for biomarker assay development and evaluation
Timeframe: Within 90 days of enrollment
3
Collection devices for detection
Timeframe: Within 90 days of enrollment
4
Characterization of endometrial neoplasia, other neoplasms, or underlying causes