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NCT06527157 | RECRUITING | Uterine Cancer

Investigations of Reproductive Cancers in Women
Sponsor:

PinkDx, Inc.

Brief 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.

Condition or disease

Uterine Cancer

Study Type : OBSERVATIONAL
Estimated Enrollment : 4500 participants
Official Title : PROspective ACcrual To Investigate reprOductive Cancers in womeN
Actual Study Start Date : 2024-07-30
Estimated Primary Completion Date : 2026-08-30
Estimated Study Completion Date : 2026-11-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years to 100 Years
Sexes Eligible for Study: FEMALE
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.
Investigations of Reproductive Cancers in Women

Location Details

NCT06527157

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama, Birmingham

Birmingham, Albama, United States, 35294

RECRUITING

United States, California

Sutter Health

Redwood City, California, United States, 94062

RECRUITING

United States, Florida

Advent Health Orlando

Orlando, Florida, United States, 32803

RECRUITING

United States, Illinois

Ob-Gyne Associates of Lake Forest, Ltd

Lake Forest, Illinois, United States, 60045

RECRUITING

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

RECRUITING

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63108

RECRUITING

United States, New York

Columbia University

New York, New York, United States, 10032

RECRUITING

United States, Ohio

Summa Health

Akron, Ohio, United States, 44304

RECRUITING

United States, Ohio

The Ohio State University

Columbus, Ohio, United States, 43210

RECRUITING

United States, South Dakota

Avera Research Institute

Sioux Falls, South Dakota, United States, 57108

RECRUITING

United States, Tennessee

University of Tennessee Health Science Center

Memphis, Tennessee, United States, 38103

RECRUITING

United States, Tennessee

Meharry Medical College

Nashville, Tennessee, United States, 37208

RECRUITING

United States, Texas

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

Houston Methodist

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78229