Observational Study for Reproductive Cancers in Women

This observational study aims to develop a non-invasive (not requiring surgery or instruments to enter the body) diagnostic test for gynecological (female reproductive organ) cancers. This test would help rule out cancer in women aged 45 and older who experience abnormal uterine bleeding or bleeding after menopause. The study will look at how well this new test works, specifically its "sensitivity" (how well it correctly identifies those with the condition) over 12 months. Women between 45 and 100 years old can participate if they are willing to follow the study plan and can be contacted by phone. The current recruitment status is unclear, and the study plans to enroll about 4500 participants.

Study design
This is an observational study with a planned enrollment of 4500 women. The phase of the study is not specified.
What's involved
You would need to comply with scheduled visits, the study plan, and other procedures. You are expected to be available for the duration of the study and contactable by telephone.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, sensitivity, is measured at 12 months.

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NCT06527157

Investigations of Reproductive Cancers in Women

Recruiting
Not specifiedAges 45+Observational
PinkDx, Inc.
~4,500 participants
Updated 2026-08-17 on ClinicalTrials.gov

At a glance

Recruiting sites
13 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity
Measured over 12 months
Uterine Cancer
16 sites across 12 states
Texas3
Ohio2
Tennessee2
Alabama1
California1
Florida1
Illinois1
Indiana1
  • Andrea Mariani, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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  • Sensitivity12 months

    ability to detect cancer