Vaginal fluid collection to detect endometrial cancer and precancer
Endometrial Cancer Vaginal Fluid Specimen Collection Study: "ENVISION"
This project will try collecting vaginal fluid to test whether new lab tests can detect endometrial cancer or precancer in people with abnormal uterine bleeding or a new diagnosis of endometrial pathology.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Exact Sciences Corporation Industry-sponsored |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Murfreesboro, Tennessee) |
| Trial ID | NCT07544680 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter specimen collection effort aimed at developing and validating laboratory tests that use vaginal fluid to detect endometrial cancer and related precancers. Participants are enrolled into two cohorts: people with abnormal uterine bleeding who are planning standard-of-care endometrial tissue sampling, and adults with biopsy-confirmed endometrial cancer or atypical hyperplasia who are planning initial management. Vaginal fluid specimens are collected alongside routine clinical care and linked to diagnostic tissue results to enable test development and performance comparison. The protocol is observational and excludes people with prior hysterectomy, current pregnancy, recent pelvic radiation, or recent chemotherapy that would confound results.
Who should consider this trial
Good fit: Ideal candidates are adults either (a) age 45 or older (or 18+ with risk factors) who have abnormal uterine bleeding and are scheduled for endometrial tissue sampling, or (b) adults with a new biopsy-confirmed diagnosis of endometrial cancer or atypical hyperplasia planning initial treatment.
Not a fit: People who have had a partial or complete hysterectomy, are currently pregnant, have had pelvic or vaginal radiotherapy, received chemotherapy in the past five years (except tamoxifen), or have other conditions that preclude participation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, these tests could enable earlier or less invasive detection of endometrial cancer or precancer from vaginal fluid samples.
How similar studies have performed: Prior pilot studies using uterine or vaginal sampling and molecular tests have shown promising early signals, but larger prospective specimen collections are still needed to validate clinical accuracy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Murfreesboro, Tennessee
- Murfreesboro Medical Clinic — Murfreesboro, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Sr. Clinical Trial Manager
- Email: ENVISION_Study_Info@exactsciences.com
- Phone: 608-982-1588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.