Can We Predict of the Response of High Risk Non Muscle Invasive Bladder Cancer Patients to Intravesical Bacillus Calmette-Guerin? The Role of Immunological Markers
NCT ID: NCT04723121
Last Updated: 2021-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
204 participants
INTERVENTIONAL
2013-03-01
2020-12-01
Brief Summary
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Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.
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Detailed Description
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Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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High risk NMIBC
Patients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered
Urine ELISA for immunological markers (IL-2 and IL-10)
IL-2 and IL-10 levels were measured in the supernatants. Natural human-produced IL-2 and IL-10 concen¬trations were determined in the urine of all patients and controls by solid phase ELISA Quantikine IL-2 Immunoassay and IL-10 Immunoassay, respectively
Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis
blood samples using QIAamp® RNA Blood Mini kit (QIAGEN, USA). 1 μg of total RNA was reverse transcribed with random primers, using High Capacity cDNA Archive Kit (Applied Biosystems, Foster City, CA, USA). RT-qPCR analysis was carried out with SYBER Green PCR Master Mix (Applied Biosystems, Foster City, CA, USA). Primers for TNF-α, CTLA4, T-bet+, GATA3+, FoxP3+ and GABDH as PCR control
Interventions
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Urine ELISA for immunological markers (IL-2 and IL-10)
IL-2 and IL-10 levels were measured in the supernatants. Natural human-produced IL-2 and IL-10 concen¬trations were determined in the urine of all patients and controls by solid phase ELISA Quantikine IL-2 Immunoassay and IL-10 Immunoassay, respectively
Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis
blood samples using QIAamp® RNA Blood Mini kit (QIAGEN, USA). 1 μg of total RNA was reverse transcribed with random primers, using High Capacity cDNA Archive Kit (Applied Biosystems, Foster City, CA, USA). RT-qPCR analysis was carried out with SYBER Green PCR Master Mix (Applied Biosystems, Foster City, CA, USA). Primers for TNF-α, CTLA4, T-bet+, GATA3+, FoxP3+ and GABDH as PCR control
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. benign pathology
3. Variant histology
4. Non urothelial carcinoma,
5. concommitent upper tract urothelial tumors, detrusor muscle invasion
6. low or intermediate risk NMIBC
18 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Amr Abdel-Lateif El-Sawy
Principal Investigator
Principal Investigators
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Amr A Elsawy
Role: PRINCIPAL_INVESTIGATOR
Urology and Nephrology Center
Locations
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Urology and Nephrology Center
Al Mansurah, DK, Egypt
Countries
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Other Identifiers
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AE20121
Identifier Type: -
Identifier Source: org_study_id
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