Status:
RECRUITING
Investigations of Reproductive Cancers in Women
Lead Sponsor:
PinkDx, Inc.
Conditions:
Uterine Cancer
Eligibility:
FEMALE
45-100 years
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 15 2026
Estimated Enrollment :
4500 Patients enrolled
Trial Details
Trial ID
NCT06527157
Start Date
July 30 2024
End Date
November 15 2026
Last Update
September 2 2025
Active Locations (16)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
2
Sutter Health
Redwood City, California, United States, 94062
3
Advent Health Orlando
Orlando, Florida, United States, 32803
4
Ob-Gyne Associates of Lake Forest, Ltd
Lake Forest, Illinois, United States, 60045