PROspective ACcrual To Investigate reprOductive Cancers in womeN

PinkDx, Inc.31 sites in 1 country4,500 target enrollmentJuly 30, 2024

ConditionsUterine Cancer

Overview

Phase: Not Applicable
Intervention: Benign
Conditions: Uterine Cancer
Sponsor: PinkDx, Inc.
Enrollment: 4500
Locations: 31
Primary Endpoint: Sensitivity
Status: Recruiting
Last Updated: 23 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 30, 2024

End Date

November 15, 2026

Last Updated

23 days ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

PinkDx, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.
•Willing and able to comply with scheduled visits, study plan, and other procedures.
•Expected to be available for the duration of the study and can be contacted by telephone during study participation.
•Females aged 45 and older (with roughly 80% of enrolled subjects over the age of 50).
•Presence of uterus.
•AUB or PMB being worked up to diagnose the cause of the bleeding

Exclusion Criteria

•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.
•Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator.
•Women who have had a hysterectomy.
•Women with a known history of endometrial cancer or uterine sarcoma.
•Women who have received prior treatment for endometrial cancer.
•Inability or unwillingness to sign informed consent.
•Clinical suspicion of pregnancy.
•Women who have used a tampon within 7 days of sample collection.