Creating a non-invasive test for ruling out gynecological cancer in women over 45

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop a non-invasive diagnostic test to help rule out gynecological cancers in women aged 45 and older who experience abnormal uterine bleeding or postmenopausal bleeding. Participants will be required to provide informed consent and comply with scheduled visits throughout the study. The focus is on identifying potential uterine cancer in this demographic, which is at a higher risk for such conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama, Birmingham
  Birmingham, Alabama, United States Recruiting
• Sutter Health
  San Carlos, California, United States Recruiting
• Advent Health Orlando
  Orlando, Florida, United States Recruiting
• Indiana University, Eskenazi Health
  Indianapolis, Indiana, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• Columbia University
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Andrea Mariani, MD — Mayo Clinic
• Study coordinator: VP, Clinical Operations
• Email: devon@pinkdx.com
• Phone: 463-273-7024

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.