Clinical trial NCT04286672: Metadherin mRNA Expression in Bladder Cancer
Official title: Serum Metadherin mRNA Expression in Bladder Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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 .

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.

Eligibility criteria: 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.

Primary outcomes:
measure: early diagnosis of bladder cancer patient
timeFrame: baseline
Secondary outcomes:
measure: non invasive marker for detection of bladder cancer.
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Lubna Mohamed Tag El-Din
name: Lubna M. Tag El-Din, Doctorate
role: STUDY_CHAIR
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