Recruiting NCT06527157
Investigations of Reproductive Cancers in Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Uterine Cancer. Basic parameters: 45 years — 100 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PROspective ACcrual To Investigate reprOductive Cancers in womeN
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.
Primary outcome measures
- Sensitivity [Time frame: 12 months]
Secondary outcome measures (1)
- Specificity [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.
- Willing and able to comply with scheduled visits, study plan, and other procedures.
- Expected to be available for the duration of the study and can be contacted by telephone during study participation.
- Females aged 45 and older (with roughly 80% of enrolled subjects over the age of 50).
- Presence of uterus.
- AUB or PMB being worked up to diagnose the cause of the bleeding
Exclusion criteria
- 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.
- Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator.
- Women who have had a hysterectomy.
- Women with a known history of endometrial cancer or uterine sarcoma.
- Women who have received prior treatment for endometrial cancer.
- Inability or unwillingness to sign informed consent.
- Clinical suspicion of pregnancy.
- Women who have used a tampon within 7 days of sample collection.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
United States · 16 centers
- University of Alabama, Birmingham — Birmingham
- Sutter Health — Redwood City
- Advent Health Orlando — Orlando
- Ob-Gyne Associates of Lake Forest, Ltd — Lake Forest
- Indiana University, Eskenazi Health — Indianapolis
- Mayo Clinic — Rochester
- Washington University School of Medicine — St Louis
- Columbia University — New York
- … and 8 more centers
Identifiers
NCT: NCT06527157 · PNK002