Investigations of Reproductive Cancers in Women

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
PinkDx, Inc.
Study ID
NCT06527157
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jul 30, 2024
Status verified
Apr 2026
Primary completion
Aug 30, 2026
Completion
Nov 15, 2026

Study Design

Enrollment
4,500 participants (estimated)

Arms

  • Arm: Benign
    sample collection from females with benign causes of AUB/PMB
  • Arm: Malignant
    sample collection from females with malignant causes of AUB/PMB

Primary Outcome Measure

Sensitivity [ Time Frame: 12 months ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
University of Alabama, BirminghamBirminghamAlabama35294
Stephanie Clevenger
[email protected]
205-934-0877
Janeen Arbuckle, MD (PRINCIPAL_INVESTIGATOR)
Sutter HealthRedwood CityCalifornia94062
Debbie Jacobs, RN, MSN
[email protected]
916-746-2132
John Hoff, MD (PRINCIPAL_INVESTIGATOR)
Advent Health OrlandoOrlandoFlorida32803
Jenni Freed, RN
[email protected]
Erica Stockwell, DO (PRINCIPAL_INVESTIGATOR)
Ob-Gyne Associates of Lake Forest, LtdLake ForestIllinois60045-
Indiana University, Eskenazi HealthIndianapolisIndiana46202
Shelley Dowden
[email protected]
317-880-3954
David M. Haas, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Taylor Rasmusson, M.S.N
[email protected]
507-266-4813
Andrea Mariani, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63108
Madison Copeland
[email protected]
314-362-4672
David Mutch, MD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Reena Vattakalam
[email protected]
212-305-3410
Jason D Wright, MD (PRINCIPAL_INVESTIGATOR)
Summa HealthAkronOhio44304
Sarah Stanaszeks
[email protected]
330-375-9753
Clarissa Polen-De, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Cindy Overholts
[email protected]
614-293-4365
Anne-Marie Sinay, MD (PRINCIPAL_INVESTIGATOR)
Avera Research InstituteSioux FallsSouth Dakota57108
Olivia Vermeulen, MD
[email protected]
Kimberlee McKay, MD (PRINCIPAL_INVESTIGATOR)
University of Tennessee Health Science CenterMemphisTennessee38103
Annette Hickerson
[email protected]
Alexa Swailes, MD (PRINCIPAL_INVESTIGATOR)
Meharry Medical CollegeNashvilleTennessee37208
Melissa Allison, MPH RN
[email protected]
615-327-3108
Baylor College of Medicine/Texas Children's HospitalHoustonTexas77030
Jennifer DeVolder, R.N.
[email protected]
832-822-7406
Nishath Ali, M.D. (PRINCIPAL_INVESTIGATOR)
Houston MethodistHoustonTexas77030
Jaya Kamath, MS
[email protected]
713-441-6616
Pedro Ramirez, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Krystin Cunningham, RN
[email protected]
210-450-8817
Sally Kabro, M.Sc.
[email protected]
708-560-1402
Georgia McCann, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama, Birmingham· Birmingham, ALSutter Health· Redwood City, CAAdvent Health Orlando· Orlando, FLOb-Gyne Associates of Lake Forest, Ltd· Lake Forest, ILIndiana University, Eskenazi Health· Indianapolis, INMayo Clinic· Rochester, MN

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