Actively Recruiting
PROspective ACcrual To Investigate reprOductive Cancers in womeN
Led by PinkDx, Inc. · Updated on 2026-04-09
4500
Participants Needed
16
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are working to develop a non-invasive test that can help rule out gynecological cancer in females aged 45 and older who have abnormal uterine or postmenopausal bleeding. This observational study focuses on understanding the causes of such bleeding to improve diagnosis in this population. The research is sponsored by PinkDx, Inc. and aims to provide clearer diagnostic options for women experiencing these symptoms. The study involves collecting samples from two groups of females: those with benign causes of abnormal uterine bleeding or postmenopausal bleeding, and those with malignant causes. There are no interventions or treatments being given as this is an observational study. Participants will be observed and their samples analyzed to identify markers that differentiate between benign and malignant causes. Participants will need to provide informed consent and comply with scheduled visits and study procedures. Researchers will monitor safety and collect data over a 12-month period, focusing on sensitivity and specificity of the diagnostic test being developed. Participants are expected to be available for the study duration and reachable by phone. The study will assess how accurately the test can identify cancer and non-cancer cases among women with abnormal bleeding.
CONDITIONS
Brief Title
Investigations of Reproductive Cancers in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent indicating understanding of the study
- Willing and able to follow scheduled visits and procedures
- Expected to be available and reachable by phone during study
- Female aged 45 years or older (about 80% over age 50)
- Presence of a uterus
- Experiencing abnormal uterine bleeding (AUB) or postmenopausal bleeding (PMB) being evaluated for cause
You will not qualify if you...
- Investigator site staff, their family members, PinkDx, Inc. employees, or their family members
- Medical or psychiatric conditions that increase risk of participation
- Women who have had a hysterectomy
- Known history of endometrial cancer or uterine sarcoma
- Prior treatment for endometrial cancer
- Unable or unwilling to sign informed consent
- Clinical suspicion of pregnancy
- Use of tampon within 7 days before sample collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants provide biological samples to investigate causes of abnormal uterine bleeding or postmenopausal bleeding.
1 to 2 visits depending on cohort assignment
Duration - 12 months
Participants are monitored to assess sensitivity and specificity over 12 months.
Periodic follow-up as needed
Trial Site Locations
Total: 16 locations
1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Sutter Health
Redwood City, California, United States, 94062
Actively Recruiting
3
Advent Health Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
4
Ob-Gyne Associates of Lake Forest, Ltd
Lake Forest, Illinois, United States, 60045
Active, Not Recruiting
5
Indiana University, Eskenazi Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
6
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Washington University School of Medicine
St Louis, Missouri, United States, 63108
Actively Recruiting
8
Columbia University
New York, New York, United States, 10032
Actively Recruiting
9
Summa Health
Akron, Ohio, United States, 44304
Actively Recruiting
10
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
11
Avera Research Institute
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
12
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38103
Actively Recruiting
13
Meharry Medical College
Nashville, Tennessee, United States, 37208
Actively Recruiting
14
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
15
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
16
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
V
VP, Clinical Operations
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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