Investigations of Reproductive Cancers in Women

Recruiting

• Conditions: Uterine Cancer

• Registration Number: NCT06527157
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Study Start: 2024-07-30
• Study First Posted: 2024-07-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-08-30
• Study Completion: 2026-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 4500

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 (with roughly 80% of enrolled subjects over the age of 50).
5. Presence of uterus.
6. AUB or PMB being evaluated to rule out cancer.

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity	12 months	ability to detect cancer

Secondary Outcome Measures

Name	Time	Method
Specificity	12 months	ability to identify benign cases

Trial Locations

Locations (11)

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States

Ob-Gyne Associates of Lake Forest, Ltd; 🇺🇸 Lake Forest, Illinois, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Columbia University; 🇺🇸 New York, New York, United States

Summa Health; 🇺🇸 Akron, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Avera Research Institute; 🇺🇸 Sioux Falls, South Dakota, United States

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States

Meharry Medical College; 🇺🇸 Nashville, Tennessee, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States