Investigations of Reproductive Cancers in Women

Last updated: March 19, 2025
Sponsor: PinkDx, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Cancer

Uterine Disorders

Uterine Fibroids

Treatment

N/A

Clinical Study ID

NCT06527157
PNK002
  • Ages 45-100
  • Female

Study Summary

The goal of this study is to create a non-invasive diagnostic test to rule out gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal bleeding.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent form indicating that thesubject 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 bytelephone during study participation.

  4. Females aged >45 (with roughly 80% of enrolled subjects over the age of 50).

  5. Presence of uterus.

  6. AUB or PMB being evaluated to rule out cancer.

Exclusion

Exclusion Criteria:

  1. Investigator site staff members directly involved in the conduct of the study andtheir family members or subjects who are PinkDx, Inc. employees or their familymembers.

  2. Other medical or psychiatric conditions that would increase the risk of studyparticipation 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.

Study Design

Total Participants: 4500
Study Start date:
July 30, 2024
Estimated Completion Date:
November 15, 2026

Connect with a study center

  • University of Alabama, Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Ob-Gyne Associates of Lake Forest, Ltd

    Lake Forest, Illinois 60045
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63108
    United States

    Active - Recruiting

  • Columbia University

    New York, New York 10032
    United States

    Active - Recruiting

  • Summa Health

    Akron, Ohio 44304
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Avera Research Institute

    Sioux Falls, South Dakota 57108
    United States

    Active - Recruiting

  • University of Tennessee Health Science Center

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

  • Meharry Medical College

    Nashville, Tennessee 37208
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.