Overview
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
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
