Bladder CancerNCT04286672
Metadherin mRNA Expression in Bladder Cancer
An observational study of Bladder Cancer, run by Assiut University.
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… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Metadherin
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 .
Who may be able to join
- Males and females.
- 30-80 years old.
- patients with bladder cancer not receiving any treatment
Who cannot join
- patients taking chemotherapy or radiotherapy.
- History of other malignancy.
- History of autoimmune diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Metadherin
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetadherinDiagnostic test
study alterations of MTDH gene expression in the serum of bladder cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Group 1: | • 35 bladder cancer patients diagnosed by biopsy before treatment. Receives: Diagnostic Test: Metadherin | |
| Group 2: | 35 apparently healthy individuals who were matched by age and sex . Receives: Diagnostic Test: Metadherin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (1)
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 .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study startDec 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Nasr Abd-el-hakim, Assiut University
- Investigators
- Lubna M. Tag El-Din, Doctorate, Study chair, Lubna Mohamed Tag El-Din
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286672
- Sponsor's protocol ID
- MmBC
- Status last verified
- Aug 2020
- First submitted
- 17 Feb 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28891275Burger 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.
PubMed 22877502Giopanou 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.
PubMed 24963474Guszcz 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.
PubMed 31897172Hu 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.
PubMed 27903708Kang 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.
PubMed 15927426Li 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.
PubMed 25092897Pan 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.
PubMed 26689985Park 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.
PubMed 27667169Sarkar 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.
PubMed 18316612Su 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.
PubMed 12032861Zhang 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.
PubMed 29312494
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Metadherin mRNA Expression in Bladder Cancer
- ClinicalTrials.gov ID
- NCT04286672
- Acronym / sponsor ID
- MmBC
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: | – | Diagnostic Test: Metadherin• 35 bladder cancer patients diagnosed by biopsy before treatment. |
| Group 2: | – | Diagnostic Test: Metadherin35 apparently healthy individuals who were matched by age and sex . |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (3 listed)
- Males and females.
- 30-80 years old.
- patients with bladder cancer not receiving any treatment
Key exclusion criteria (3 listed)
- patients taking chemotherapy or radiotherapy.
- History of other malignancy.
- History of autoimmune diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metadherinstudy alterations of MTDH gene expression in the serum of bladder cancer patients | Diagnostic test | Group 1:, Group 2: |
Primary outcome
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.
1 secondary outcome
non invasive marker for detection of bladder cancer.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Results publication: PubMed 28891275Abdel-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.
- Results publication: PubMed 22877502Burger 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.
- Results publication: PubMed 24963474Giopanou 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.
- Results publication: PubMed 31897172Guszcz 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.
- Results publication: PubMed 27903708Hu 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.
- Results publication: PubMed 15927426Kang 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.
- Results publication: PubMed 25092897Li 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.
- Results publication: PubMed 26689985Pan 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.
- Results publication: PubMed 27667169Park 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.
- Results publication: PubMed 18316612Sarkar 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.
- Results publication: PubMed 12032861Su 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.
- Results publication: PubMed 29312494Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lubna M. Tag El-Din, Doctorate study chair
Lubna Mohamed Tag El-Din
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa N. Abd-el-Hakim, Master (01007246740, esraanasr1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early diagnosis of bladder cancer patient (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04286672, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.