Endometrial Cancer Vaginal Fluid Specimen Collection Study (ENVISION)

April 15, 2026 updated by: Exact Sciences Corporation

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

4200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Recruiting
        • Murfreesboro Medical Clinic
        • Contact:
        • Principal Investigator:
          • Brad Chesney, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1
Participants undergoing clinical evaluation for AUB
Cohort 2
Participants diagnosed with EC or AEH/EIN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of clinically characterized vaginal fluid specimens
Time Frame: Within 90 days of enrollment.
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
Time Frame: Within 90 days of enrollment
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
Time Frame: Within 90 days of enrollment
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
Time Frame: Within 90 days of enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exact Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

April 24, 2028

Study Completion (Estimated)

April 24, 2028

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include test, tables, figures, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable), and the clinical study report (when applicable) will also be shared.

IPD Sharing Time Frame

Data will be available from 2 years and ending 4 years after publication.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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