Bladder CancerimmunoBLADNCT06334406
Antitumor T Cell Responses in Patients With Bladder Cancer
An observational study of Bladder Cancer, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor. 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?
- Biological samples
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2024to 2 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for a bladder cancer
Who may be able to join
- Patients undergoing transurethral resection of the bladder (TURBT) for a tumor detected by cystoscopy with a histological diagnosis of a non-infiltrating or muscle-infiltrating tumor
- For muscle-invasive tumors: localized tumors (T2-T3N0M0) or locally advanced (T4N0M0)
- Written informed consent
Who cannot join
- History of TURBT for a bladder tumor whatever the stage
- Stages N1-3 or M1 on initial assessment
- Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
- History of cancer in the last 3 years other than basal cell carcinoma or non-invasive cervical cancer
- HIV, hepatitis C or B infection
- Patients with any medical or psychiatric condition or disease,
- Patients under guardianship, curatorship or under the protection of justice.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of Antitumor T Cell Immune Responses in Patients With Bladder Cancer
The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor.
- Conditions
- Bladder Cancer
- Being tested
- Biological samples
- 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.
Biological samplesOther
Blood samples will be collected at baseline, after the diagnostic TURBT, and D15 after the end of treatment in each cohort.
Tumor tissues will be collected at baseline for three patients.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients treated with intravesical instillations for non-invasive bladder cancer Receives: Other: Biological samples | |
| Cohort B | Patients treated with radiotherapy (+/- concurrent chemotherapy) for invasive bladder cancer Receives: Other: Biological samples | |
| Cohort C | Patients treated with neo-adjuvant chemotherapy for invasive bladder cancer Receives: Other: Biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor antigen specific T-cell responses
Increase in the post-treatment sample of at least 30% in the level of anti-TERT Th1 lymphocytes in the blood measured by the ELISpot IFN-γ method, compared to the measurement at baseline.
Measured: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Secondary outcomes (7)
Monitoring of T cells in the blood
Flow cytometry analysis using T cell markers for : activation (ICOS, CD137, OX40), differenciation (CD45RA, CCR7, CD62L, CD95), cytotoxicity (perforin, granzyme B, GNLY, SlamF7) and exhaustion (PD-1, TIM-3, TIGIT, TCF1, CD39)
Measured: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Monitoring of immune cell death parameters in the blood
ATP and HMGB1 by ELISA test
Measured: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Monitoring of immune suppressive cells in the blood
Flow cytometry analysis using Treg markers (CD3, CD4, CD25, CD127, Foxp3) and monocytic MDSC (CD14, CD11b, CD33, HLA-DR, and lineage cocktail CD3 CD19 CD56).
Measured: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Overall survival
Time between the date of diagnosis and the date of death from any cause
Measured: Date of death from any cause (within 2 years after the initiation of the treatment)
Progression-free survival
Time interval between the date of diagnosis and the date of first progression (local, pelvic, metastatic [extent of the disease by RECIST v1.1]) or death from any cause
Measured: date of first progression of the disease (within 2 year after the initiation of the treatment)
Local progression-free survival
Time interval between the date of diagnosis and the date of first local progression or death from any cause
Measured: date of first local progression of the disease (within 2 year after the initiation of the treatment)
Transcriptomic analysis
Expression of genes of the anti-tumor responses in blood and tumor
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start2 Apr 2024 (estimated)
- Primary completion2 Apr 2026 (estimated)
- Study completion2 Apr 2026 (estimated)
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 Centre Hospitalier Universitaire de BesanconThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334406
- Sponsor's protocol ID
- 098 DRC 210 ER03 012
- Acronym
- immunoBLAD
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Antitumor T Cell Immune Responses in Patients With Bladder Cancer
- ClinicalTrials.gov ID
- NCT06334406
- Acronym / sponsor ID
- immunoBLAD / 098 DRC 210 ER03 012
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 2 Apr 2024 (estimated)
- Primary completion
- 2 Apr 2026 (estimated)
- Study completion
- 2 Apr 2026 (estimated)
- First posted
- 28 Mar 2024 (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 main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: Biological samplesPatients treated with intravesical instillations for non-invasive bladder cancer |
| Cohort B | – | Other: Biological samplesPatients treated with radiotherapy (+/- concurrent chemotherapy) for invasive bladder cancer |
| Cohort C | – | Other: Biological samplesPatients treated with neo-adjuvant chemotherapy for invasive bladder cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for a bladder cancer
Key inclusion criteria (3 listed)
- Patients undergoing transurethral resection of the bladder (TURBT) for a tumor detected by cystoscopy with a histological diagnosis of a non-infiltrating or muscle-infiltrating tumor
- For muscle-invasive tumors: localized tumors (T2-T3N0M0) or locally advanced (T4N0M0)
- Written informed consent
Key exclusion criteria (7 listed)
- History of TURBT for a bladder tumor whatever the stage
- Stages N1-3 or M1 on initial assessment
- Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
- History of cancer in the last 3 years other than basal cell carcinoma or non-invasive cervical cancer
- HIV, hepatitis C or B infection
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 |
|---|---|---|
| Biological samplesBlood samples will be collected at baseline, after the diagnostic TURBT, and D15 after the end of treatment in each cohort. Tumor tissues will be collected at baseline for three patients. | Other | Cohort A, Cohort B, Cohort C |
Primary outcome
Tumor antigen specific T-cell responses
Time frame: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Increase in the post-treatment sample of at least 30% in the level of anti-TERT Th1 lymphocytes in the blood measured by the ELISpot IFN-γ method, compared to the measurement at baseline.
7 secondary outcomes
Monitoring of T cells in the blood
Time frame: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Monitoring of immune cell death parameters in the blood
Time frame: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Monitoring of immune suppressive cells in the blood
Time frame: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Overall survival
Time frame: Date of death from any cause (within 2 years after the initiation of the treatment)
Progression-free survival
Time frame: date of first progression of the disease (within 2 year after the initiation of the treatment)
Local progression-free survival
Time frame: date of first local progression of the disease (within 2 year after the initiation of the treatment)
Transcriptomic analysis
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Centre Hospitalier Universitaire de Besancon.
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 7 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 28 Mar 2024. 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 Jihane Boustani, MD, PhD (+33 3 70 63 23 02, jboustani@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor antigen specific T-cell responses (time frame: 15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)). 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 28 Mar 2024.