NCT07544680 Endometrial Cancer Vaginal Fluid Specimen Collection Study
| NCT ID | NCT07544680 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Exact Sciences Corporation |
| Condition | Abnormal Uterine Bleeding (AUB) |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,200 participants |
| Start Date | 2026-03-10 |
| Primary Completion | 2028-04-24 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,200 participants in total. It began in 2026-03-10 with a primary completion date of 2028-04-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07544680 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Abnormal Uterine Bleeding (AUB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07544680 currently recruiting?
Yes, NCT07544680 is actively recruiting participants. Contact the research team at ENVISION_Study_Info@exactsciences.com for enrollment information.
Where is the NCT07544680 trial being conducted?
This trial is being conducted at Sarasota, United States, Scarborough, United States, Murfreesboro, United States, Murfreesboro, United States and 1 additional location.
Who is sponsoring the NCT07544680 clinical trial?
NCT07544680 is sponsored by Exact Sciences Corporation. The trial plans to enroll 4,200 participants.