Evaluation of MCM5 in postmenopausal bleeding patients
Research type
Research Study
Full title
Utilising an innovative MCM5 Urine TEst foR the dIagnosis of eNdometrial cancEr (MCM5-UTERINE study)
IRAS ID
302967
Contact name
Richard Edmondson
Contact email
Sponsor organisation
Arquer Diagnostics Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
The objective of this study is to determine if Arquer’s diagnostic test (ADXGYNAE) can detect which patients with postmenopausal bleeding may have endometrial cancer. Previous studies using the test have shown that by detecting a substance in the urine called MCM5 the ADXGYNAE test could reliably determine which patients had endometrial cancer. In total 1000-1200 patients attending the gynaecology clinic for postmenopausal bleeding will be recruited and asked to provide a urine sample to be tested. The patient will then have routine tests and the results will be recorded and compared to Arquer’s ADXGYNAE test. This will allow the research team to see if the test could be useful in helping to diagnose endometrial cancer. The results of the ADXGYNAE test will not influence the treatment of the patients during the study in any way and all patients will have all the standard tests as normal. .
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0241
Date of REC Opinion
7 Jan 2022
REC opinion
Further Information Favourable Opinion