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Swab test could spot hidden uterine cancer early

NCT ID NCT07544680

Diagnosis Sponsor: Exact Sciences Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 6 times

Summary

This study is collecting vaginal fluid samples from 4,200 people to develop a new test for endometrial cancer. Participants include those with abnormal uterine bleeding or a recent endometrial cancer diagnosis. The goal is to find biomarkers that could lead to a simple, non-invasive screening tool.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 4,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atypical endometrial hyperplasia endometrial cancer Endometrial Hyperplasia endometrium neoplasm Metrorrhagia precancerous condition

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abnormal uterine bleeding (AUB) Atypical endometrial hyperplasia Endometrial cancer Endometrial hyperplasia with atypia Endometrial intraepithelial neoplasia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IC Research

    RECRUITING

    Murfreesboro, Tennessee, 37132, United States

  • MaineHealth

    RECRUITING

    Scarborough, Maine, 04070, United States

  • Murfreesboro Medical Clinic

    RECRUITING

    Murfreesboro, Tennessee, 37130, United States

  • National Research Center - Frisco

    RECRUITING

    Frisco, Texas, 75034, United States

  • Physical Care Clinical Research

    RECRUITING

    Sarasota, Florida, 34249, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.