Clinical Trials in the USA / NCT06527157
Recruiting
Observational
Investigations of Reproductive Cancers in Women
NCT06527157 · tracked via the Priya Life Science USA tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
Study of NEO-201 in Solid Tumors Expansion Cohorts
Active, not recruiting
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