Symptoms and General Pathology

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Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Hemorrhage

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Antibodies

Antibodies, Monoclonal

Immunoglobulins

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

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.

MCM5 ELISA

Jacqueline Stockley, PhD

Prof Richard Edmondson

Professor Richard Edmondson, MD

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.

Evaluation of MCM5 in Postmenopausal Bleeding Patients

A Performance Evaluation Study of Arquer Diagnostics Ltd's MCM5 ELISA (ADXGYNAE) Test to Aid in the Diagnosis 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.

Arquer Diagnostics Ltd

Recurrence

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Disease Attributes

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients with a previous diagnosis of non-muscle invasive bladder cancer, attending a urology clinic for the purposes of bladder cancer recurrence monitoring.

ADXBLADDER is a non-invasive, qualitative ELISA utilising a combination of two monoclonal antibodies for the detection of MCM5 in urine sediment. It is intended to aid in the monitoring of bladder cancer recurrence in non-muscle-invasive bladder cancer patients. Participants will be asked to provide a full void urine specimen, which will be centrifuged before the urine sediment is lysed. The lysed sample will then be tested with ADXBLADDER.

ADXBLADDER

Larry Karsh, MD

Martin K. Deneen, MD

James Bailen, MD

Jason Hafron, MD

Louis Keeler, MD

Christopher Pieczonka, MD

Lawrence A. Gervasi, MD

Laurence Belkoff, MD

Neal Shore, MD

Jose De La Cerda, MD

Eugene Kramolowsky, MD

Michael Williams, MD

Raymond Lance, MD

Professor Ashish Kamat

The objective of this prospective, multi-centre study is to evaluate the performance of ADXBLADDER, a urine MCM5 ELISA test, as an aid in the detection of bladder cancer recurrence. Patients undergoing cystoscopic surveillance in non-muscle invasive bladder cancer (NMIBC) follow-up will be recruited and asked to provide a urine sample to be tested with ADXBLADDER. To assess the diagnostic accuracy of the test, the MCM5 results will be compared with the gold standard cystoscopy and pathology of resected tissue.

A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer

The ADXBLADDER MCM5 results will be compared with the definitive diagnosis obtained by gold standard cystoscopy and pathological assessment of suspicious lesion(s) (where clinically indicated).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of MCM5 in Postmenopausal Bleeding Patients	NCT05287048	Endometrial Can...	MCM5 ELISA	18 Years -	Arquer Diagnostics Ltd
A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer	NCT05508568	Bladder Cancer	ADXBLADDER	22 Years -	Arquer Diagnostics Ltd

Spots Global Cancer Trial Database for mcm5

Every month we try and update this database with for mcm5 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mcm5

Every month we try and update this database with for mcm5 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mcm5 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.