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RecruitingObservational

PROspective ACcrual To Investigate reprOductive Cancers in womeN

NCT ID: NCT06527157Sponsor: PinkDx, Inc.Last updated: 2026-06-18

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.

Arms & interventions

Outcome measures

Primary

  • Sensitivity

    ability to detect cancer

    Time frame: 12 months

Secondary

  • Specificity

    Time frame: 12 months

Eligibility criteria

Sex: FemaleAge: 45 Years to 100 Years
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 locations (16)

University of Alabama, Birmingham

Birmingham, Alabama, 35294

Recruiting
Stephanie Clevenger · Contact
Janeen Arbuckle, MD · Principal Investigator

Sutter Health

Redwood City, California, 94062

Recruiting
Debbie Jacobs, RN, MSN · Contact
John Hoff, MD · Principal Investigator

Advent Health Orlando

Orlando, Florida, 32803

Recruiting
Jenni Freed, RN · Contact
Erica Stockwell, DO · Principal Investigator

Ob-Gyne Associates of Lake Forest, Ltd

Lake Forest, Illinois, 60045

Active Not Recruiting

Indiana University, Eskenazi Health

Indianapolis, Indiana, 46202

Recruiting
Shelley Dowden · Contact
David M. Haas, MD · Principal Investigator

Mayo Clinic

Rochester, Minnesota, 55905

Active Not Recruiting

Washington University School of Medicine

St Louis, Missouri, 63108

Recruiting
Madison Copeland · Contact
David Mutch, MD · Principal Investigator

Columbia University

New York, New York, 10032

Recruiting
Reena Vattakalam · Contact
Jason D Wright, MD · Principal Investigator

Summa Health

Akron, Ohio, 44304

Recruiting
Sarah Stanaszeks · Contact
Clarissa Polen-De, MD · Principal Investigator

The Ohio State University

Columbus, Ohio, 43210

Recruiting
Cindy Overholts · Contact
Anne-Marie Sinay, MD · Principal Investigator

Avera Research Institute

Sioux Falls, South Dakota, 57108

Active Not Recruiting

University of Tennessee Health Science Center

Memphis, Tennessee, 38103

Recruiting
Annette Hickerson · Contact
Alexa Swailes, MD · Principal Investigator

Meharry Medical College

Nashville, Tennessee, 37208

Recruiting
Melissa Allison, MPH RN · Contact

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, 77030

Recruiting
Jennifer DeVolder, R.N. · Contact
Nishath Ali, M.D. · Principal Investigator

Houston Methodist

Houston, Texas, 77030

Recruiting
Pedro Ramirez, MD · Principal Investigator

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Recruiting
Krystin Cunningham, RN · Contact
Sally Kabro, M.Sc. · Contact
Georgia McCann, MD · Principal Investigator