Metadherin mRNA Expression in Bladder Cancer

September 27, 2020 updated by: Esraa Nasr Abd-el-hakim, Assiut University

Serum Metadherin mRNA Expression in Bladder Cancer

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1:
• 35 bladder cancer patients diagnosed by biopsy before treatment.
Diagnostic test: Metadherin
study alterations of MTDH gene expression in the serum of bladder cancer patients
Group 2:
35 apparently healthy individuals who were matched by age and sex .
Diagnostic test: Metadherin
study alterations of MTDH gene expression in the serum of bladder cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early diagnosis of bladder cancer patient
Time Frame: 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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
non invasive marker for detection of bladder cancer.
Time Frame: 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 .
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Lubna M. Tag El-Din, Doctorate, Lubna Mohamed Tag El-Din

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MmBC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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