Metadherin mRNA Expression in Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Serum Metadherin mRNA Expression in Bladder Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04286672
• Other study ID #: MmBC
• Status: Not yet recruiting
• Start date: December 2020
• Est. completion date: January 2022

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: Esraa N. Abd-el-Hakim, Master
• Phone: 01007246740
• Email: esraanasr1991[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: January 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• Metadherin
study alterations of MTDH gene expression in the serum of bladder cancer patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (12)

Abdel-Rahman O, Helbling D, Schöb O, Eltobgy M, Mohamed H, Schmidt J, Giryes A, Mehrabi A, Iype S, John H, Tekbas A, Zidan A, Oweira H. Cigarette smoking as a risk factor for the development of and mortality from hepatocellular carcinoma: An updated syste — View Citation

Burger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz P, Kassouf W, Kiemeney LA, La Vecchia C, Shariat S, Lotan Y. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol. 2013 Feb;63(2):234-41. doi: 10.1016/j.eururo.2012.07.033. E — View Citation

Giopanou I, Bravou V, Papanastasopoulos P, Lilis I, Aroukatos P, Papachristou D, Kounelis S, Papadaki H. Metadherin, p50, and p65 expression in epithelial ovarian neoplasms: an immunohistochemical study. Biomed Res Int. 2014;2014:178410. doi: 10.1155/2014 — View Citation

Guszcz T, Szymanska B, Kozlowski R, Lukaszewski Z, Laskowski P, Gorodkiewicz E. Plasma aromatase as a sensitive and selective potential biomarker of bladder cancer and its role in tumorigenesis. Oncol Lett. 2020 Jan;19(1):562-568. doi: 10.3892/ol.2019.110 — View Citation

Hu B, Emdad L, Kegelman TP, Shen XN, Das SK, Sarkar D, Fisher PB. Astrocyte Elevated Gene-1 Regulates ß-Catenin Signaling to Maintain Glioma Stem-like Stemness and Self-Renewal. Mol Cancer Res. 2017 Feb;15(2):225-233. doi: 10.1158/1541-7786.MCR-16-0239. E — View Citation

Kang DC, Su ZZ, Sarkar D, Emdad L, Volsky DJ, Fisher PB. Cloning and characterization of HIV-1-inducible astrocyte elevated gene-1, AEG-1. Gene. 2005 Jun 20;353(1):8-15. — View Citation

Li G, Wang Z, Ye J, Zhang X, Wu H, Peng J, Song W, Chen C, Cai S, He Y, Xu J. Uncontrolled inflammation induced by AEG-1 promotes gastric cancer and poor prognosis. Cancer Res. 2014 Oct 1;74(19):5541-52. doi: 10.1158/0008-5472.CAN-14-0968. Epub 2014 Aug 4 — View Citation

Pan Y, Guo X, Yang Z, Chen S, Lei Y, Lin M, Wang L, Feng C, Ke Z. AEG-1 activates Wnt/PCP signaling to promote metastasis in tongue squamous cell carcinoma. Oncotarget. 2016 Jan 12;7(2):2093-104. doi: 10.18632/oncotarget.6573. — View Citation

Park SY, Choi M, Park D, Jeong M, Ahn KS, Lee J, Fisher PB, Yun M, Lee SG. AEG-1 promotes mesenchymal transition through the activation of Rho GTPases in human glioblastoma cells. Oncol Rep. 2016 Nov;36(5):2641-2646. doi: 10.3892/or.2016.5106. Epub 2016 S — View Citation

Sarkar D, Park ES, Emdad L, Lee SG, Su ZZ, Fisher PB. Molecular basis of nuclear factor-kappaB activation by astrocyte elevated gene-1. Cancer Res. 2008 Mar 1;68(5):1478-84. doi: 10.1158/0008-5472.CAN-07-6164. — View Citation

Su ZZ, Kang DC, Chen Y, Pekarskaya O, Chao W, Volsky DJ, Fisher PB. Identification and cloning of human astrocyte genes displaying elevated expression after infection with HIV-1 or exposure to HIV-1 envelope glycoprotein by rapid subtraction hybridization — View Citation

Zhang L, Yang G, Chen H, Huang Y, Xue W, Bo J. Depletion of astrocyte elevated gene-1 suppresses tumorigenesis through inhibition of Akt activity in bladder cancer cells. Am J Transl Res. 2017 Dec 15;9(12):5422-5431. eCollection 2017. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early diagnosis of bladder cancer patient	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	non invasive marker for detection of bladder cancer.	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