Recruiting

Reproductive Cancers

Sponsor:

PinkDx, Inc.

Code:

NCT06527157

Conditions

Uterine Cancer

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Uterine Cancer

Study ID

NCT06527157

Start date

Jul 30, 2024

Status verified date

Aug, 2026

Completion date

Nov 15, 2031

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

4500 participants

Anticipated

Interventions and Outcome Measures

Arms

Benign

sample collection from females with benign causes of AUB/PMB

Malignant

sample collection from females with malignant causes of AUB/PMB

Primary outcome measure

  • Sensitivity [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

VP, Clinical Operations

463-273-7024devon@pinkdx.com

Locations

University of Alabama, Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Principal Investigator:

Janeen Arbuckle, MD

Sutter Health

Recruiting

San Carlos, California, United States, 94070

Contacts

Principal Investigator:

John Hoff, MD, PhD

Advent Health Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Principal Investigator:

Erica Stockwell, DO

Indiana University, Eskenazi Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

David M. Haas, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Principal Investigator:

David Mutch, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Jason D Wright, MD

Summa Health

Recruiting

Akron, Ohio, United States, 44304

Contacts

Principal Investigator:

Clarissa Polen-De, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Anne-Marie Sinay, MD

University of Tennessee Health Science Center

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Annette Hickerson

abpayne@uthsc.edu

Principal Investigator:

Alexa Swailes, MD

Meharry Medical College

Recruiting

Nashville, Tennessee, United States, 37208

Contacts

Baylor College of Medicine/Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Nishath Ali, M.D.

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Pedro Ramirez, MD

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Georgia McCann, MD

More Information

Sponsor

PinkDx, Inc.

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PinkDx, Inc. on 2026-08-17.