Evaluation of MCM5 in Postmenopausal Bleeding Patients (NCT05287048) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of MCM5 in Postmenopausal Bleeding Patients
United Kingdom2,000 participantsStarted 2022-03-01
Plain-language summary
The objective of this multi-centre, prospective study, is to evaluate the performance of a urine MCM5 ELISA test (ADXGYNAE) in the detection of endometrial cancer in patients with postmenopausal bleeding. Patients attending a gynaecology clinic for investigation of postmenopausal bleeding will be recruited and asked to provide a urine sample to be tested. The results of the MCM5 test will be recorded and compared to the patient's routine investigations to determine the clinical utility of the test as an aid in the diagnosis of endometrial cancer.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients 18 years of age or older
* Patients who are at least 1 year post-menopausal i.e. have not had a menstrual period for at least one year
* Patients who, in the opinion of the Investigator, are suitable for standard gynaecological investigations as part of normal clinical practice
* Patients who are, in the opinion of the Investigator, able to understand the purpose of the study and provide a full void urine specimen
* Patients who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained
Exclusion Criteria:
* Patients with known symptomatic calculi within the urino-genitary system
* Patients currently undergoing chemotherapy or radiotherapy
* Patients who have previously been diagnosed with bladder or renal cancer who are currently in follow up
* Patients with a medical contraindication to endometrial biopsy
* Patients who do not wish to have an endometrial biopsy even if deemed necessary by the treating physician
* Patients who have had urological instrumentation to the urinary tract within 14 days prior to the test (including catheterisation)
* Patients who have had any gynaecological instrumentation in the previous 14 days
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity, specificity and negative predictive value (NPV) of ADXGYNAE will be calculated to establish the diagnostic accuracy for the detection of endometrial cancer.