Bladder CancerALUNCT04412070
Assessement of the Concordance of Genomic Alterations Between Urine and Tissue in High-Risk NMIBC Patients
An observational study of Bladder Cancer, run by Hopital Foch at 1 site in France.
Trial summary
The analysis of cell-free tumor DNA (cfDNA) in plasma has emerged as a clinically relevant predictive and prognostic biomarker in several metastatic solid malignancies, and even now represents standard-of-care for prescription of some targeted therapies in non-small cell lung cancer (blood-based T790M companion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2021to 30 Jun 2025
- 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: The study population concerns : * Group 1 : patients with high-risk NMIBC treated by BCG therapy * Group 2 : patients with MIBC treated by radical cystectomy. This group will be considered as a positive control. During their conventional follow-up, a urine collection will be performed to each patient for testing of cell-free DNA. Genomic analysis of the primary tumor will be carried out on the tumor samples resetced during the initial diagnosis.
Who may be able to join
- Common Inclusion Criteria
- Age ≥18 years at the time of screening.
- Capable of giving signed informed consent
- BCG-naïve (patients who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry are eligible).
- No prior radiotherapy to the bladder.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Show all 36Show fewer
- At screening, tumor tissue provision from the initial surgery, formalin-fixed and paraffin-embedded (FFPE) is mandatory for DNA extraction and next-generation sequencing.
- Absence of metastasis, as confirmed by a negative CT or MRI scan of the pelvis, abdomen and chest, no more than 4 weeks prior to the enrolment.
- Life expectancy of at least 12 weeks.
- Must be a candidate for BCG treatment.
- Adequate organ and marrow function as defined below:
- Hemoglobin ≥9.0 g/dL Absolute neutrophil count ≥1.0 × 109/L Platelet count ≥75 × 109/L Serum bilirubin ≤1.5 × the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN Measured creatinine clearance (CL) >40 mL/min or calculated creatinine CL >40 mL/min as determined by Cockcroft-Gault (using actual body weight) Males Creatinine CL = (Weight (kg) × (140 - Age))/(72 × serum creatinine (mg/dL)) (mL/min)
- Females Creatinine CL = (Weight (kg) × (140 - Age) )/(72 × serum creatinine (mg/dL)) × 0.85 (mL/min) - Being covered by a national health insurance
- Specific Inclusion Criteria for Non-Muscle Invasive Bladder Cancer (NMIBC) group
- Local histological confirmation (based on pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa (predominantly urothelial even though mixed histology are allowed). A high-risk tumor is defined as one of the following:
- T1 tumor
- High grade/G3 tumor
- CIS
- Multiple and recurrent and large (with diameter of largest evaluable node ≥3 cm) tumors (all conditions must be met in this point)
- Complete resection of all Ta/T1 papillary disease prior to enrolment, with the most recent TURBT (Trans Urethral Resection of Bladder Tumor) occurring 2 months or less prior to signing informed consent for this study. Patients with residual CIS after TURBT are eligible.
- At least one additional resection of the primary tumor has been performed in case of T1 tumors, or incomplete initial TURB, or in case of doubt about the completeness of a TURB, or if there is no muscle in the specimen (can be omitted if primary CIS (In situ cancer) only was found.)
- Specific Inclusion Criteria for Muscle Invasive Bladder Cancer (MIBC) group Patients with histologically proven muscle-invasive bladder cancer (MIBC) scheduled before radical cystectomy.
- Non-Inclusion Criteria:
- Common Non-inclusion Criteria
- Evidence of lymphovascular invasion of bladder tumor, except if treatment with BCG is deemed to be the only clinically viable treatment (ie, clinical candidates of cystectomy and/or chemotherapy, etc are excluded).
- Known or documented absolute and/or relative contraindication of adjuvant intravesical BCG treatment.
- Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive transitional cell carcinoma of the urothelium.
- Any concurrent chemotherapy, Intra Peritoneal, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
- Concurrent treatment with systemic immunostimulatory agents prior to the first dose of study treatment.
- History of allogenic organ transplantation. Patients with any history of allogenic stem cell transplantation are also excluded
- History of active primary immunodeficiency
- Pregnant or breastfeeding women
- Being deprived of liberty or under guardianship
- Specific Non-inclusion Criteria for NMIBC group
- Evidence of muscle-invasive, locally advanced, metastatic, and/or extra-vesical bladder cancer (ie, T2, T3, T4, and / or stage IV)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Concordance of Genomic Alterations Between Urine and Tissue to Develop Precision Medicine-Based Immunotherapy Approaches in High-Risk NMIBC Patients
The analysis of cell-free tumor DNA (cfDNA) in plasma has emerged as a clinically relevant predictive and prognostic biomarker in several metastatic solid malignancies, and even now represents standard-of-care for prescription of some targeted therapies in non-small cell lung cancer (blood-based T790M companion diagnostic test). cfDNA can be detected not only in plasma but also in urine, even in patients with non-invasive disease. Recent studies found that the detection of genomic alterations in plasma of urothelial bladder carcinoma patients was relatively uninformative in the localized setting. However, urine cfDNA has been shown to provide a promising resource for robust whole-genome tumor profiling in clinically localized Muscle invasive Bladder cancer (MIBC) and Non-Muscle Invasive Bladder Cancer (NMIBC). Genomic alterations using a targeted next-generation sequencing (NGS) panel have been recently documented in a series of treatment-naïve high-risk NMIBC.
The investigator's aim is to determine whether liquid biopsies can be used as a new diagnostic assay to guide immunotherapeutic approaches in patients with high-risk NMIBC. The ultimate goal is to develop a "testing decision tree" to segment patients for informing on therapeutic decision and customizing treatment.
- Conditions
- Bladder Cancer
- Keywords
- Muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Cancer, cfDNA
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with Non-Muscle invasive Bladder Cancer | Patients in this group will be enrolled before the start of their treatment with BCG. This will start within 4 weeks after the transurethral bladder resection, in accordance with the guidelines | |
| Patient with Muscle Invasive Bladder Cancer | Patients in this group will be enrolled in the study before surgical treatment by radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement rate between urine cell-free DNA and tumor tissue mutation profile
concordance rate between mutations identified in the tumor
Measured: Day 0
Secondary outcomes (1)
Prognostic value of Tumor Mutation Burden (TMB)
TMB will be calculated in the urine cell-free DNA for Each patient
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start30 Jul 2021
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Why it stopped: The target enrollment was not reached at the end of recrutement period. The presence of a concurrent therapeutic clinical trial in the same department significantly limited patient availability for this study, making further recruitment not feasible.
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.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Yanish Soorojebally, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412070
- Sponsor's protocol ID
- 2018_0087
- Acronym
- ALU
- Status last verified
- Nov 2025
- First submitted
- 28 May 2020
- Last updated
- 21 Nov 2025
- 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Concordance of Genomic Alterations Between Urine and Tissue to Develop Precision Medicine-Based Immunotherapy Approaches in High-Risk NMIBC Patients
- ClinicalTrials.gov ID
- NCT04412070
- Acronym / sponsor ID
- ALU / 2018_0087
- Conditions
- Bladder Cancer
- Keywords
- Muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Cancer, cfDNA
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The target enrollment was not reached at the end of recrutement period. The presence of a concurrent therapeutic clinical trial in the same department significantly limited patient availability for this study, making further recruitment not feasible.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 2 Jun 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 analysis of cell-free tumor DNA (cfDNA) in plasma has emerged as a clinically relevant predictive and prognostic biomarker in several metastatic solid malignancies, and even now represents standard-of-care for prescription of some targeted therapies in non-small cell lung cancer (blood-based T790M companion diagnostic test). cfDNA can be detected not only in plasma but also in urine, even in patients with non-invasive disease. Recent studies found that the detection of genomic alterations in plasma of urothelial bladder carcinoma patients was relatively uninformative in the localized setting. However, urine cfDNA has been shown to provide a promising resource for robust whole-genome tumor profiling in clinically localized Muscle invasive Bladder cancer (MIBC) and Non-Muscle Invasive Bladder Cancer (NMIBC). Genomic alterations using a targeted next-generation sequencing (NGS) panel have been recently documented in a series of treatment-naïve high-risk NMIBC.
The investigator's aim is to determine whether liquid biopsies can be used as a new diagnostic assay to guide immunotherapeutic approaches in patients with high-risk NMIBC. The ultimate goal is to develop a "testing decision tree" to segment patients for informing on therapeutic decision and customizing treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with Non-Muscle invasive Bladder Cancer | – | –Patients in this group will be enrolled before the start of their treatment with BCG. This will start within 4 weeks after the transurethral bladder resection, in accordance with the guidelines |
| Patient with Muscle Invasive Bladder Cancer | – | –Patients in this group will be enrolled in the study before surgical treatment by radical cystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population concerns : * Group 1 : patients with high-risk NMIBC treated by BCG therapy * Group 2 : patients with MIBC treated by radical cystectomy. This group will be considered as a positive control. During their conventional follow-up, a urine collection will be performed to each patient for testing of cell-free DNA. Genomic analysis of the primary tumor will be carried out on the tumor samples resetced during the initial diagnosis.
Key inclusion criteria (36 listed)
- Common Inclusion Criteria
- Age ≥18 years at the time of screening.
- Capable of giving signed informed consent
- BCG-naïve (patients who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry are eligible).
- No prior radiotherapy to the bladder.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement rate between urine cell-free DNA and tumor tissue mutation profile
Time frame: Day 0
concordance rate between mutations identified in the tumor
1 secondary outcome
Prognostic value of Tumor Mutation Burden (TMB)
Time frame: Day 0
Results and safety
The study was stopped early (reason given: The target enrollment was not reached at the end of recrutement period. The presence of a concurrent therapeutic clinical trial in the same department significantly limited patient availability for this study, making further recruitment not feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- 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.
Yanish Soorojebally, MD principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Hopital Foch at 1 site in France.
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 36 inclusion and 0 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: stopped early, as of the sponsor's last update on 21 Nov 2025. 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 France. 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 was stopped early (reason given: The target enrollment was not reached at the end of recrutement period. The presence of a concurrent therapeutic clinical trial in the same department significantly limited patient availability for this study, making further recruitment not feasible.). Results are not available in the source record.
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?
Agreement rate between urine cell-free DNA and tumor tissue mutation profile (time frame: Day 0). 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 21 Nov 2025.