Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
4500 participants
OBSERVATIONAL
2024-07-30
2026-11-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Collecting Tumor Samples From Patients With Gynecological Tumors
NCT00897442
The Study of Massively Parallel Sequencing in Early Detection for Gynecologic Malignant Tumor
NCT02166515
Early Detection of Cancers in Low Resource Countries
NCT01178736
Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood
NCT06082765
Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples
NCT01793545
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Benign
sample collection from females with benign causes of AUB/PMB
No interventions assigned to this group
Malignant
sample collection from females with malignant causes of AUB/PMB
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
45 Years
100 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PinkDx, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrea Mariani, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama, Birmingham
Birmingham, Alabama, United States
Sutter Health
Redwood City, California, United States
Advent Health Orlando
Orlando, Florida, United States
Ob-Gyne Associates of Lake Forest, Ltd
Lake Forest, Illinois, United States
Indiana University, Eskenazi Health
Indianapolis, Indiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St 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/Texas Children's Hospital
Houston, Texas, United States
Houston Methodist
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Stephanie Clevenger
Role: primary
Maureen Tart, M.D.
Role: primary
Reena Vattakalam
Role: primary
Shannon Khoenle
Role: primary
Kimberlee McKay, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PNK002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.