Bladder CancerNCT04723121
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
A study testing Urine ELISA for immunological markers (IL-2 and IL-10) and Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis in people with Bladder Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Urine ELISA for immunological markers (IL-2 and IL-10) and Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2013to 1 Dec 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with primary or recurrent NMIBC for whom primary TURBT was done.
Who cannot join
- Patients with previous BCG instillation,
- benign pathology
- Variant histology
- Non urothelial carcinoma,
- concommitent upper tract urothelial tumors, detrusor muscle invasion
- low or intermediate risk NMIBC
Trial locations and contacts
1 site in 1 country.
About this study
Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage.
Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.
Read the detailed description
Background: Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage.
Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.
- Conditions
- Bladder Cancer
- Being tested
- Urine ELISA for immunological markers (IL-2 and IL-10), Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis
- Keywords
- Bladder cancer, Bacillus Calmette-Guérin response, Prediction, Urinary cytokines, T cells, Recurrence, Progression
- Medical subject headings
- Urinary Bladder Neoplasms, Recurrence, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine ELISA for immunological markers (IL-2 and IL-10)Diagnostic test
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) analysisDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| High risk NMIBC | Other | Patients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered Receives: Diagnostic Test: Urine ELISA for immunological markers (IL-2 and IL-10); Diagnostic Test: Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial BCG complete response
free cystoscopy/negative cytology at 3 months.
Measured: 3 months
Recurrence
Recurrence is defined as development of new tumor/positive cytology in patients with ICR
Measured: 1 year
Progression
persistent/recurrent tumor during or after treatment with increasing tumor grade or upstaging to muscle invasion after initial complete response
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Mar 2013
- Primary completion1 May 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel-Lateif El-Sawy, Mansoura University
- Investigators
- Amr A Elsawy, Principal investigator, Urology and Nephrology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723121
- Sponsor's protocol ID
- AE20121
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04723121
- Acronym / sponsor ID
- AE20121
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, Bacillus Calmette-Guérin response, Prediction, Urinary cytokines, T cells, Recurrence, Progression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 25 Jan 2021 (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.
Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage.
Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.
Detailed description
Background: Intravesical BCG is the mainstay adjuvant management of high risk NMIBC. Adequacy of immune system stimulation is the determinant factor for patient response to BCG. Immunological markers for BCG-response could be helpful for urologists especially in the era of BCG shortage.
Objectives: To assess the predictive performance of different immunological markers on BCG-response in high risk NMIBC BCG-naïve patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High risk NMIBC | Other | Diagnostic Test: Urine ELISA for immunological markers (IL-2 and IL-10), Diagnostic Test: Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysisPatients with primary or recurrent NMIBC for whom primary TURBT was done and intravesical BCG was administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with primary or recurrent NMIBC for whom primary TURBT was done.
Key exclusion criteria (6 listed)
- Patients with previous BCG instillation,
- benign pathology
- Variant histology
- Non urothelial carcinoma,
- concommitent upper tract urothelial tumors, detrusor muscle invasion
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 |
|---|---|---|
| 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 | Diagnostic test | High risk NMIBC |
| Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysisblood 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 | Diagnostic test | High risk NMIBC |
Primary outcome
Initial BCG complete response
Time frame: 3 months
free cystoscopy/negative cytology at 3 months.
Recurrence
Time frame: 1 year
Recurrence is defined as development of new tumor/positive cytology in patients with ICR
Progression
Time frame: 1 year
persistent/recurrent tumor during or after treatment with increasing tumor grade or upstaging to muscle invasion after initial complete response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- 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.
Amr A Elsawy principal investigator
Urology and Nephrology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine ELISA for immunological markers (IL-2 and IL-10) and Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis in people with Bladder Cancer, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial BCG complete response (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2021.