Comparing blood and tissue tests for genetic changes in bladder cancer
CtDNA-FGFR Status As a Predictive Biomarker for FGFR Targeted Therapy
This study is trying to see if a blood test can find important genetic changes in bladder cancer better than a tissue test, so more patients can get the right treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | British Columbia Cancer Agency Academic / other |
| Drugs / interventions | erdafitinib |
| Locations | 7 sites (Calgary, Alberta and 6 other locations) |
| Trial ID | NCT06129084 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of circulating tumor DNA (ctDNA) blood testing compared to standard tumor tissue testing for identifying genetic changes in patients with metastatic bladder cancer. The aim is to determine if blood tests can provide a more accurate assessment of FGFR mutations, which are necessary for treatment eligibility with the drug erdafitinib. Patients will have both blood and tissue samples analyzed to see if ctDNA testing can identify more patients who could benefit from this targeted therapy. The study seeks to improve diagnostic accuracy and treatment outcomes for patients with this aggressive cancer.
Who should consider this trial
Good fit: Ideal candidates are patients with metastatic bladder cancer who are scheduled for FGFR tissue testing and can provide blood samples.
Not a fit: Patients who will not undergo tissue testing for FGFR mutations will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable more patients to receive effective treatment for metastatic bladder cancer by improving the accuracy of genetic testing.
How similar studies have performed: Other studies have shown promise in using ctDNA testing for various cancers, suggesting that this approach may be beneficial, although this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with metastatic bladder cancer who are about to undergo tissue testing for FGFR mutations and who have blood samples drawn during the management of their disease are eligible to be included in this analysis. Exclusion Criteria: * Metastatic bladder cancer patients who will not have tissue sent for FGFR testing will be excluded from this study.
Where this trial is running
Calgary, Alberta and 6 other locations
- Arthur J.E Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (Recruiting)
- Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)
- BC Cancer Agency — Vancouver, British Columbia, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- CHU de Québec-Université Laval — Québec City, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Clinical Research and Trials Coordinator
- Email: lisa.rebane@bccancer.bc.ca
- Phone: 604-877-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.