RECRUITING

Investigations of Reproductive Cancers in Women

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Conditions

Uterine Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

PROspective ACcrual To Investigate reprOductive Cancers in womeN

Quick Facts

Study Start:2024-07-30
Study Completion:2026-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06527157

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.

Ages Eligible for Study:45 Years to 100 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Willing and able to comply with scheduled visits, study plan, and other procedures.
  3. 3. Expected to be available for the duration of the study and can be contacted by telephone during study participation.
  4. 4. Females aged \>45 (with roughly 80% of enrolled subjects over the age of 50).
  5. 5. Presence of uterus.
  6. 6. AUB or PMB being evaluated to rule out cancer or for benign conditions such as fibroids, pelvic organ prolapse, ovarian cysts, etc.
  1. 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. 2. Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator.
  3. 3. Women who have had a hysterectomy.
  4. 4. Women with a known history of endometrial cancer or uterine sarcoma.
  5. 5. Women who have received prior treatment for endometrial cancer.
  6. 6. Inability or unwillingness to sign informed consent.
  7. 7. Clinical suspicion of pregnancy.
  8. 8. Women who have used a tampon within 7 days of sample collection.

Contacts and Locations

Study Contact

VP, Clinical Operations
CONTACT
463-273-7024
devon@pinkdx.com

Principal Investigator

Andrea Mariani, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

University of Alabama, Birmingham
Birmingham, Alabama, 35294
United States
Ob-Gyne Associates of Lake Forest, Ltd
Lake Forest, Illinois, 60045
United States
Summa Health
Akron, Ohio, 44304
United States

Collaborators and Investigators

Sponsor: PinkDx, Inc.

  • Andrea Mariani, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-30
Study Completion Date2026-11-15

Study Record Updates

Study Start Date2024-07-30
Study Completion Date2026-11-15

Terms related to this study

Additional Relevant MeSH Terms

  • Uterine Cancer