Ireland
--:--IST
Recruiting Observational

Investigations of Reproductive Cancers in Women

NCT06527157 · tracked via the Priya Life Science USA tracker
Sponsor
PinkDx, Inc
Phase
Observational
Started
2024-07-30
Last updated
2026-08-17

Condition(s) studied

Uterine Cancer

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

Sex
FEMALE
Min age
45 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Sensitivity — 12 months
    ability to detect cancer

Trial sites (16)

FacilityCityRegionStatus
University of Alabama, Birmingham Birmingham Alabama Recruiting
Sutter Health San Carlos California Recruiting
Advent Health Orlando Orlando Florida Recruiting
Ob-Gyne Associates of Lake Forest, Ltd Lake Forest Illinois Active Not Recruiting
Indiana University, Eskenazi Health Indianapolis Indiana Recruiting
Mayo Clinic Rochester Minnesota Active Not Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Columbia University New York New York Recruiting
Summa Health Akron Ohio Recruiting
The Ohio State University Columbus Ohio Recruiting
Avera Research Institute Sioux Falls South Dakota Active Not Recruiting
University of Tennessee Health Science Center Memphis Tennessee Recruiting
Meharry Medical College Nashville Tennessee Recruiting
Baylor College of Medicine/Texas Children's Hospital Houston Texas Recruiting
Houston Methodist Houston Texas Recruiting
University of Texas Health Science Center at San Antonio San Antonio Texas Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06527157 on ClinicalTrials.gov ↗ ← All trials in the USA