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NCT Number: NCT07544680

Endometrial Cancer Vaginal Fluid Specimen Collection Study

This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.

Recruiting

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Key information

Conditions

Abnormal Uterine Bleeding (AUB) Atypical Endometrial Hyperplasia Endometrial Cancer Endometrial Hyperplasia Endometrial Hyperplasia With Atypia Endometrial Intraepithelial Neoplasia Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Hemorrhage Metrorrhagia Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Hemorrhage Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Murfreesboro Medical Clinic

Murfreesboro, Tennessee, 37130, United States

Location status: Recruiting

Location contact

Brad Chesney, MD

PRINCIPAL_INVESTIGATOR

Miles Guy

CONTACT

[email protected]

615-410-3460

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sr. Clinical Trial Manager

CONTACT

[email protected]

608-982-1588

Sponsors and collaborators

Lead sponsor

Exact Sciences Corporation

Industry

Registry information

Official study title

Endometrial Cancer Vaginal Fluid Specimen Collection Study: "ENVISION"

Acronym: ENVISION

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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