Metadherin mRNA Expression in Bladder Cancer

• Conditions: Bladder Cancer
• Interventions: Diagnostic Test: Metadherin

• Registration Number: NCT04286672
• Lead Sponsor: Assiut University

Brief Summary

The study aims to study alterations of MTDH gene expression in the serum of bladder cancer patients compared to control group to evaluate its role as a marker for diagnosis.

,to compare the diagnostic accuracy of MTDH with the previously used marker Bladder Cancer-Specific Antigen-1 (BLCA-1 in the serum of bladder cancer patients .

and to study correlation between expression of the metadherin gene and serum level of BLCA-1, and clinical and histopathological staging in patients with bladder cancer

Detailed Description

Urinary bladder cancer (BC) is the ninth most common cancer worldwide. It is the fifth most common malignancy in males and seventeenth most common in females.

In Egypt, bladder cancer represents a massive health burden where it is one of the commonest cancers representing 6.9% in both sexes and 10.7% among men. Its distribution is 8.8% in lower Egypt, 14.2% in middle Egypt and 12.6% in upper Egypt.Almost 50% of patients will experience recurrence of their disease within 4 years of their initial diagnosis.The prognosis of bladder cancer is poor as a result of highly invasive properties of tumour cells.

The optimal treatment selection depends on early diagnosis as well as accurate staging and grading.Currently there is a need for new molecular bio markers that can help clinicians to identify patients requiring early, aggressive treatment.

Metadherin (MTDH) is an oncogene known as Astrocytic elevated gene-1(AEG-1).It was firstly identified in 2002 at fetal astrocytes of persons exposed to HIV-1 and then known as a vital oncogene mediating carcinogenesis,prognosis,invasion and cancer metastasis. AEG-1 expression is raised in bladder cancer tissues relative to normal tissues, and serves as a poor prognostic factor.

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Status Verified: 2020-08
• Last Update Submitted: 2020-09-27
• Last Update Posted: 2020-09-29
• Study Start: 2020-12
• Primary Completion: 2021-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Males and females.
• 30-80 years old.
• patients with bladder cancer not receiving any treatment

Exclusion Criteria

1. patients taking chemotherapy or radiotherapy.
2. History of other malignancy.
3. History of autoimmune diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2:	Metadherin	35 apparently healthy individuals who were matched by age and sex .
Group 1:	Metadherin	• 35 bladder cancer patients diagnosed by biopsy before treatment.

Primary Outcome Measures

Name	Time	Method
early diagnosis of bladder cancer patient	baseline	study mRNA MTDH expression in the serum of bladder cancer patients compared to control group to evaluate its role as a marker for diagnosis.

Secondary Outcome Measures

Name	Time	Method
non invasive marker for detection of bladder cancer.	baseline	To compare the diagnostic accuracy of MTDH with the previously used marker Bladder Cancer-Specific Antigen-1 (BLCA-1 in the serum of bladder cancer patients .