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New test could spare women unnecessary biopsies for uterine cancer

NCT ID NCT06527157

Diagnosis Sponsor: PinkDx, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 18, 2026 · Updated 4 times

Summary

This study is working on a new, non-invasive test to help rule out uterine cancer in women aged 45 and older who have abnormal bleeding. Researchers will collect samples from 4,500 women to see how well the test detects cancer and identifies benign cases. If successful, it could reduce the need for invasive procedures like biopsies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple, non-invasive test to rule out uterine cancer, reducing the need for biopsies and other invasive procedures.
What could go wrong
This is an early-stage diagnostic study, not a treatment trial. The test may not be accurate enough to replace current methods, and results may not apply to all populations.

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 4,500 people

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

Started

Jul 2024

Expected to finish

Nov 2031

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

Females 45 years and older seeking medical attention for abnormal uterine or postmenopausal bleeding.

Ages

45 to 100 years

Sex

Female participants only

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: 1. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study. 2. Willing and able to comply with scheduled visits, study plan, and other procedures. 3. Expected to be available for the duration of the study and can be contacted by telephone during study participation. 4. Females aged 45 and older (with roughly 80% of enrolled subjects over the age of 50). 5. Presence of uterus. 6. AUB or PMB being worked up to diagnose the cause of the bleeding Exclusion Criteria: 1. Investigator site staff members directly involved in the conduct of the study and their family members or subjects who are PinkDx, Inc. employees or their family members. 2. Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator. 3. Women who have had a hysterectomy. 4. Women with a known history of endometrial cancer or uterine sarcoma. 5. Women who have received prior treatment for endometrial cancer. 6. Inability or unwillingness to sign informed consent. 7. Clinical suspicion of pregnancy. 8. Women who have used a tampon within 7 days of sample collection.

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Conditions

The condition(s) this trial relates to.

uterine cancer

As listed by the trial registrant

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

Uterine cancer

How to take part

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

  1. The places running it

    13 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

  • Advent Health Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Avera Research Institute

    ACTIVE_NOT_RECRUITING

    Sioux Falls, South Dakota, 57108, United States

  • Baylor College of Medicine/Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Houston Methodist

    RECRUITING

    Houston, Texas, 77030, United States

  • Indiana University, Eskenazi Health

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Mayo Clinic

    ACTIVE_NOT_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Meharry Medical College

    RECRUITING

    Nashville, Tennessee, 37208, United States

  • Ob-Gyne Associates of Lake Forest, Ltd

    ACTIVE_NOT_RECRUITING

    Lake Forest, Illinois, 60045, United States

  • Summa Health

    RECRUITING

    Akron, Ohio, 44304, United States

  • Sutter Health

    RECRUITING

    San Carlos, California, 94070, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University of Alabama, Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Tennessee Health Science Center

    RECRUITING

    Memphis, Tennessee, 38103, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63108, United States

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