Evaluation of MCM5 in Postmenopausal Bleeding Patients

NCT05287048 | Unknown

• 1 other identifier: AQ010
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

Endometrial cancer; Postmenopausal bleeding; MCM5; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with postmenopausal bleeding

Patients attending a gynaecology clinic for investigation of postmenopausal bleeding and undergoing a transvaginal ultrasound (TVUS).

Diagnostic Test: MCM5 ELISA

Interventions

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.

Also known as: ADXGYNAE

Patients with postmenopausal bleeding

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arquer Diagnostics Ltd: lead

Study Sites (1)

Saint Mary's Hospital, Central Manchester NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 33059604 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine sediment lysate samples

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Professor Richard Edmondson, MD

  Central Manchester NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Stockley, PhD

CONTACT

+44 191 516 6764; jacqui@arquerdx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 18, 2022
• Study Start: March 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)