Endometrial Cancer Vaginal Fluid Specimen Collection Study

NCT07544680 | Recruiting

• 1 other identifier: 2024-01
• Study Type: observational
• Target: 4,200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Abnormal Uterine Bleeding (AUB); Endometrial Cancer (EC); Atypical Endometrial Hyperplasia (AEH); Endometrial Hyperplasia with Atypia; Endometrial Intraepithelial Neoplasia (EIN); Precancerous Conditions; Post-Menopausal Bleeding; Specimen Collection; Sample Collection; in vitro diagnostic (IVD) devices

Outcome Measures

Primary Outcomes (4)

• Collection of clinically characterized vaginal fluid specimens

  Vaginal fluid specimens will be collected during a standard clinical exam using a swab-based collection method. Specimens will be used for research purposes to support the development of biomarker assays. No specific biomarkers or analytical methods are defined as part of this study.

  Within 90 days of enrollment.

• Clinical data for biomarker assay development and evaluation

  Clinical information will be collected as part of routine study participation and used to describe the study population and support research analyses. Data will be used in aggregate to contextualize research findings and inform future assay development.

  Within 90 days of enrollment

• Collection devices for detection

  Specimens will be collected using swab-based collection devices intended solely for specimen collection. These devices do not provide diagnostic results and are not used for clinical decision-making.

  Within 90 days of enrollment

• Characterization of endometrial neoplasia, other neoplasms, or underlying causes

  Characterization will be based on existing clinical assessments and diagnoses obtained through standard medical care. The study does not establish diagnostic criteria or endpoints and is intended for research and development purposes only.

  Within 90 days of enrollment

Study Arms (2)

Cohort 1

Participants undergoing clinical evaluation for AUB

Cohort 2

Participants diagnosed with EC or AEH/EIN

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving routine clinical care within participating primary care, gynecology, oncology, and Veterans Affairs health systems across rural, urban, and suburban regions of the United States.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Exact Sciences Corporation: lead

Study Sites (1)

Murfreesboro Medical Clinic

Murfreesboro, Tennessee, 37130, United States

RECRUITING

MeSH Terms

Conditions

Metrorrhagia; Endometrial Neoplasms; Endometrial Hyperplasia; Precancerous Conditions

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Sr. Clinical Trial Manager

CONTACT

608-982-1588; ENVISION_Study_Info@exactsciences.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 22, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): April 24, 2028
• Study Completion (Estimated): April 24, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available from 2 years and ending 4 years after publication.
• Access Criteria: Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/IEC approvals or waivers as applicable to conduct research

Locations

US (1)