Clinical trial NCT05287048: Evaluation of MCM5 in Postmenopausal Bleeding Patients
Official title: A Performance Evaluation Study of Arquer Diagnostics Ltd's MCM5 ELISA (ADXGYNAE) Test to Aid in the Diagnosis of Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Keywords: Endometrial cancer
Postmenopausal bleeding
MCM5
Biomarker
Lead sponsor: Arquer Diagnostics Ltd
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with postmenopausal bleeding attending a gynaecology clinic for transvaginal ultrasound, who are suspected of having endometrial cancer.

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity, specificity and negative predictive value (NPV) of ADXGYNAE will be calculated to establish the diagnostic accuracy for the detection of endometrial cancer.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Saint Mary's Hospital, Central Manchester NHS Foundation Trust
Study officials:
affiliation: Central Manchester NHS Foundation Trust
name: Professor Richard Edmondson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stockley J, Akhand R, Kennedy A, Nyberg C, Crosbie EJ, Edmondson RJ. Detection of MCM5 as a novel non-invasive aid for the diagnosis of endometrial and ovarian tumours. BMC Cancer. 2020 Oct 15;20(1):1000. doi: 10.1186/s12885-020-07468-y.