NCT04286672

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 29, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

February 17, 2020

Last Update Submit

September 27, 2020

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • non invasive marker for detection of bladder cancer.

    baseline

Study Arms (2)

Group 1:

• 35 bladder cancer patients diagnosed by biopsy before treatment.

Diagnostic Test: Metadherin

Group 2:

35 apparently healthy individuals who were matched by age and sex .

Diagnostic Test: Metadherin

Interventions

MetadherinDIAGNOSTIC_TEST

study alterations of MTDH gene expression in the serum of bladder cancer patients

Group 1:Group 2:

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 .

You may qualify if:

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

You may not qualify if:

  • patients taking chemotherapy or radiotherapy.
  • History of other malignancy.
  • History of autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Abdel-Rahman O, Helbling D, Schob 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 systematic review of 81 epidemiological studies. J Evid Based Med. 2017 Nov;10(4):245-254. doi: 10.1111/jebm.12270. Epub 2017 Sep 10.

    PMID: 28891275RESULT

  • 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. Epub 2012 Jul 25.

    PMID: 22877502RESULT

  • 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: 10.1155/2014/178410. Epub 2014 May 22.

    PMID: 24963474RESULT

  • 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.2019.11080. Epub 2019 Nov 11.

    PMID: 31897172RESULT

  • Hu B, Emdad L, Kegelman TP, Shen XN, Das SK, Sarkar D, Fisher PB. Astrocyte Elevated Gene-1 Regulates beta-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. Epub 2016 Nov 30.

    PMID: 27903708RESULT

  • 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. doi: 10.1016/j.gene.2005.04.006.

    PMID: 15927426RESULT

  • 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.

    PMID: 25092897RESULT

  • 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.

    PMID: 26689985RESULT

  • 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 Sep 19.

    PMID: 27667169RESULT

  • 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.

    PMID: 18316612RESULT

  • 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, RaSH. Oncogene. 2002 May 16;21(22):3592-602. doi: 10.1038/sj.onc.1205445.

    PMID: 12032861RESULT

  • 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.

    PMID: 29312494RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Lubna M. Tag El-Din, Doctorate

    Lubna Mohamed Tag El-Din

    STUDY CHAIR

Central Study Contacts

Esraa N. Abd-el-Hakim, Master

CONTACT

01007246740esraanasr1991@gmail.com

Amal M. Abdel -Aal, Doctorate

CONTACT

01225433428amalabdelaaal95@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 27, 2020

Study Start

December 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

September 29, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share