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 range18 Years
SexFEMALE
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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
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