Evaluation of MCM5 in Postmenopausal Bleeding Patients

Arquer Diagnostics

Status

Enrolling

Conditions

Endometrial Cancer

Treatments

Diagnostic Test: MCM5 ELISA

Study type

Observational

Funder types

Industry

Identifiers

NCT05287048

AQ010

Details and patient eligibility

About

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.

Enrollment

2,000 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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