NCT07544680Recruiting
Endometrial Cancer Vaginal Fluid Specimen Collection Study
Exact Sciences Corporation
Start Date
3/10/2026
Completion Date
4/24/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Conditions
Abnormal Uterine Bleeding (AUB)Endometrial CancerAtypical Endometrial HyperplasiaEndometrial Hyperplasia With AtypiaEndometrial Intraepithelial Neoplasia
Locations
Murfreesboro Medical Clinic
Murfreesboro, Tennessee 37130
United States