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

PROspective ACcrual To Investigate reprOductive Cancers in womeN

Observational PinkDx, Inc. · NCT06527157

This study is testing a new non-invasive test to see if it can help women over 45 with abnormal bleeding find out if they have gynecological cancer.

Quick facts

Study typeObservational
Enrollment4500 (estimated)
Ages45 Years to 100 Years
SexFemale
SponsorPinkDx, Inc. Industry-sponsored
Locations16 sites (Birmingham, Alabama and 15 other locations)
Trial IDNCT06527157 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 45 and older who are experiencing abnormal uterine bleeding or postmenopausal bleeding.

Not a fit: Patients who have had a hysterectomy or a known history of endometrial cancer or uterine sarcoma will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more accessible method for early detection of uterine cancer in women.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in developing non-invasive diagnostic methods for gynecological cancers.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Uterine Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.