Status:
UNKNOWN
Evaluation of MCM5 in Postmenopausal Bleeding Patients
Lead Sponsor:
Arquer Diagnostics Ltd
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Brief 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 bleed...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT05287048
Start Date
March 1 2022
End Date
September 1 2023
Last Update
February 1 2023
Active Locations (1)
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1
Saint Mary's Hospital, Central Manchester NHS Foundation Trust
Manchester, United Kingdom, M13 9WL