Investigations of Reproductive Cancers in Women

Recruiting now

Conditions studied: Uterine Cancer

In brief

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.

Key facts

Study ID

NCT06527157

Run by

PinkDx, Inc.

People needed

4500

Starts

2024-07-30

Expected to finish

2031-11-15

Last updated by the study team

2026-06-18

Who can join

Age: 45 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.
• Willing and able to comply with scheduled visits, study plan, and other procedures.
• Expected to be available for the duration of the study and can be contacted by telephone during study participation.
• Females aged 45 and older (with roughly 80% of enrolled subjects over the age of 50).
• Presence of uterus.
• AUB or PMB being worked up to diagnose the cause of the bleeding

You may not qualify if…

• 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.
• Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator.
• Women who have had a hysterectomy.
• Women with a known history of endometrial cancer or uterine sarcoma.
• Women who have received prior treatment for endometrial cancer.
• Inability or unwillingness to sign informed consent.
• Clinical suspicion of pregnancy.
• Women who have used a tampon within 7 days of sample collection.

Where it is running

• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (enrolling)
• Sutter Health — Redwood City, California, United States (enrolling)
• Advent Health Orlando — Orlando, Florida, United States (enrolling)
• Baylor College of Medicine/Texas Children's Hospital — Houston, Texas, United States (enrolling)
• Houston Methodist — Houston, Texas, United States (enrolling)
• University of Alabama, Birmingham — Birmingham, Alabama, United States (enrolling)
• Indiana University, Eskenazi Health — Indianapolis, Indiana, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Columbia University — New York, New York, United States (enrolling)
• Summa Health — Akron, Ohio, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• University of Tennessee Health Science Center — Memphis, Tennessee, United States (enrolling)
• Meharry Medical College — Nashville, Tennessee, United States (enrolling)
• Ob-Gyne Associates of Lake Forest, Ltd — Lake Forest, Illinois, United States
• Avera Research Institute — Sioux Falls, South Dakota, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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