RecruitingNCT07544680

Endometrial Cancer Vaginal Fluid Specimen Collection Study

Endometrial Cancer Vaginal Fluid Specimen Collection Study: "ENVISION"

Sponsor

Exact Sciences Corporation

Enrollment

4,200 participants

Start Date

Mar 10, 2026

Study Type

OBSERVATIONAL

Conditions

Endometrial Cancer Endometrial Intraepithelial Neoplasia Atypical Endometrial Hyperplasia Abnormal Uterine Bleeding (AUB)Endometrial Hyperplasia With Atypia

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

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 Criteria16

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