Endometrial Cancer Vaginal Fluid Specimen Collection Study

Endometrial Cancer Vaginal Fluid Specimen Collection Study: "ENVISION"

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

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