Investigations of Reproductive Cancers in Women (PROACTION:)

April 3, 2026 updated by: PinkDx, Inc.

PROspective ACcrual To Investigate reprOductive Cancers in womeN

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: VP, Clinical Operations
  • Phone Number: 463-273-7024
  • Email: devon@pinkdx.com

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama, Birmingham
        • Contact:
        • Principal Investigator:
          • Janeen Arbuckle, MD
    • California
      • Redwood City, California, United States, 94062
        • Recruiting
        • Sutter Health
        • Contact:
        • Principal Investigator:
          • John Hoff, MD
    • Florida
      • Orlando, Florida, United States, 32803
    • Illinois
      • Lake Forest, Illinois, United States, 60045
        • Active, not recruiting
        • Ob-Gyne Associates of Lake Forest, Ltd
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University, Eskenazi Health
        • Contact:
          • Shelley Dowden
          • Phone Number: 317-880-3954
          • Email: sburn@iu.edu
        • Principal Investigator:
          • David M. Haas, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Andrea Mariani, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • David Mutch, MD
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Principal Investigator:
          • Jason D Wright, MD
        • Contact:
    • Ohio
      • Akron, Ohio, United States, 44304
        • Recruiting
        • Summa Health
        • Principal Investigator:
          • Clarissa Polen-De, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • Anne-Marie Sinay, MD
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Recruiting
        • Avera Research Institute
        • Principal Investigator:
          • Kimberlee McKay, MD
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • University of Tennessee Health Science Center
        • Contact:
        • Principal Investigator:
          • Alexa Swailes, MD
      • Nashville, Tennessee, United States, 37208
        • Recruiting
        • Meharry Medical College
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist
        • Contact:
        • Principal Investigator:
          • Pedro Ramirez, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Texas Children's Hospital
        • Contact:
        • Principal Investigator:
          • Nishath Ali, M.D.
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Contact:
        • Principal Investigator:
          • Georgia McCann, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Females 45 years and older seeking medical attention for abnormal uterine or postmenopausal bleeding.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Benign
sample collection from females with benign causes of AUB/PMB
Malignant
sample collection from females with malignant causes of AUB/PMB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 12 months
ability to detect cancer
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: 12 months
ability to identify benign cases
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PinkDx, Inc.

Investigators

  • Principal Investigator: Andrea Mariani, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNK002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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