Endometrial Cancer Vaginal Fluid Specimen Collection Study

Recruiting now

Conditions studied: Abnormal Uterine Bleeding (AUB), Endometrial Cancer, Atypical Endometrial Hyperplasia, Endometrial Hyperplasia With Atypia, Endometrial Intraepithelial Neoplasia

In brief

This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.

Key facts

Study ID

NCT07544680

Run by

Exact Sciences Corporation

People needed

4200

Starts

2026-03-10

Expected to finish

2028-04-24

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Physical Care Clinical Research — Sarasota, Florida, United States (enrolling)
• MaineHealth — Scarborough, Maine, United States (enrolling)
• Murfreesboro Medical Clinic — Murfreesboro, Tennessee, United States (enrolling)
• IC Research — Murfreesboro, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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