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NCT06527157Recruiting

Investigations of Reproductive Cancers in Women

PinkDx, Inc.

Start Date

7/30/2024

Completion Date

11/15/2031

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

Age Range: 45 years to 100 years

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.

Interested in This Trial?

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Conditions

Uterine Cancer

Locations

University of Alabama, Birmingham

Birmingham, Alabama 35294

United States

Sutter Health

Redwood City, California 94062

United States

Advent Health Orlando

Orlando, Florida 32803

United States

Ob-Gyne Associates of Lake Forest, Ltd

Lake Forest, Illinois 60045

United States

Indiana University, Eskenazi Health

Indianapolis, Indiana 46202

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Washington University School of Medicine

St Louis, Missouri 63108

United States

Columbia University

New York, New York 10032

United States

Summa Health

Akron, Ohio 44304

United States

The Ohio State University

Columbus, Ohio 43210

United States

Avera Research Institute

Sioux Falls, South Dakota 57108

United States

University of Tennessee Health Science Center

Memphis, Tennessee 38103

United States

Meharry Medical College

Nashville, Tennessee 37208

United States

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas 77030

United States

Houston Methodist

Houston, Texas 77030

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas 78229

United States