Investigations of Reproductive Cancers in Women (PROACTION:)

PinkDx, Inc.

Status: Enrolling

Conditions: Uterine Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT06527157

PNK002

Details and patient eligibility

About

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.

Enrollment: 4,500 estimated patients

Sex: Female

Ages: 45 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

4,500 participants in 2 patient groups

Benign

Description:

sample collection from females with benign causes of AUB/PMB

Malignant

Description:

sample collection from females with malignant causes of AUB/PMB