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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with postmenopausal bleeding | Patients attending a gynaecology clinic for investigation of postmenopausal bleeding and undergoing a transvaginal ultrasound (TVUS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCM5 ELISA | Diagnostic Test | ADXGYNAE is a non-invasive ELISA utilising a combination of two monoclonal antibodies for the detection of MCM5 in urine sediment. It is intended to aid in the detection of endometrial cancer in women with postmenopausal bleeding who are suspected of having endometrial cancer. Participants will be asked to provide a urine specimen, which will be centrifuged before the sediment is lysed. The lysed sample will then be tested with the MCM5 ELISA. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity and negative predictive value (NPV) of ADXGYNAE will be calculated to establish the diagnostic accuracy for the detection of endometrial cancer. | The MCM5 test result will be compared with data obtained from patient's standard of care clinical investigations, including results from transvaginal ultrasound (TVUS) and endometrial biopsy or hysteroscopy. A definitive diagnosis of endometrial cancer will be confirmed by the presence of histologically proven endometrial cancer on resection/biopsy. Patients who do not have an endometrial biopsy will be followed up at 6 months to identify if further investigations were carried out. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with postmenopausal bleeding attending a gynaecology clinic for transvaginal ultrasound, who are suspected of having endometrial cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Stockley, PhD | Contact | +44 191 516 6764 | jacqui@arquerdx.com |
| Name | Affiliation | Role |
|---|---|---|
| Professor Richard Edmondson, MD | Central Manchester NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Mary's Hospital, Central Manchester NHS Foundation Trust | Recruiting | Manchester | M13 9WL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33059604 | Background | 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. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Urine sediment lysate samples
|
|
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |