Investigations of Reproductive Cancers in Women

Description

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.

Conditions

Uterine Cancer

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Study Overview

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Study Details

Study overview

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.

PROspective ACcrual To Investigate reprOductive Cancers in womeN

Investigations of Reproductive Cancers in Women

Condition
Uterine Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama, Birmingham, Birmingham, Alabama, United States, 35294

Lake Forest

Ob-Gyne Associates of Lake Forest, Ltd, Lake Forest, Illinois, United States, 60045

Akron

Summa Health, Akron, Ohio, United States, 44304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 or for benign conditions such as fibroids, pelvic organ prolapse, ovarian cysts, etc.
  • 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.

Ages Eligible for Study

45 Years to 100 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

PinkDx, Inc.,

Andrea Mariani, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2026-11-15