Recruiting

Observational Study

Sponsor:

Exact Sciences Corporation

Code:

NCT07544680

Conditions

Abnormal Uterine Bleeding (AUB)

Endometrial Cancer

Atypical Endometrial Hyperplasia

Endometrial Hyperplasia With Atypia

Endometrial Intraepithelial Neoplasia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07544680

Start date

Mar 10, 2026

Status verified date

Jul, 2026

Completion date

Apr 24, 2028

Anticipated

Primary completion date

Apr 24, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

4200 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Participants undergoing clinical evaluation for AUB

Cohort 2

Participants diagnosed with EC or AEH/EIN

Primary outcome measure

  • Collection of clinically characterized vaginal fluid specimens [ Time Frame: Within 90 days of enrollment. ]
  • Clinical data for biomarker assay development and evaluation [ Time Frame: Within 90 days of enrollment ]
  • Collection devices for detection [ Time Frame: Within 90 days of enrollment ]
  • Characterization of endometrial neoplasia, other neoplasms, or underlying causes [ Time Frame: Within 90 days of enrollment ]

Central Contacts and Locations

Central contacts

Clinical Trial Manager

608-982-1588ENVISION_Study_Info@exactsciences.com

Locations

Physical Care Clinical Research

Recruiting

Sarasota, Florida, United States, 34249

Contacts

Research Coordinator

941-954-2355JAranda@PCCRSarasota.com

Principal Investigator:

Gregory Michael Swor, MD

MaineHealth

Recruiting

Scarborough, Maine, United States, 04070

Contacts

Study Coordinator

207-606-7347ntro@mainehealth.org

Principal Investigator:

Leslie Bradford, MD

Murfreesboro Medical Clinic

Recruiting

Murfreesboro, Tennessee, United States, 37130

Contacts

Miles Guy

615-410-3460mguy@icresearch.net

Principal Investigator:

Brad Chesney, MD

IC Research

Recruiting

Murfreesboro, Tennessee, United States, 37132

Contacts

Miles Guy

615-410-3460mguy@icresearch.net

Principal Investigator:

Brad Chesney, MD

National Research Center - Frisco

Recruiting

Frisco, Texas, United States, 75034

Contacts

Virginia Chacin

786-375-6210vchacin@nrcinc.com

Principal Investigator:

Henry Ramirez, MD

More Information

Sponsor

Exact Sciences Corporation

Last update posted

Aug 27, 2026

Last verified

Jul, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Exact Sciences Corporation on 2026-08-27.