Clinical trial · Observational
A Study to Compare the Results of FGFR Testing by Either ctDNA Blood Testing or Standard Tumor Tissue Testing
ctDNA-FGFR Status as a Predictive Biomarker for FGFR Targeted Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A new drug, erdafitinib, became available for some patients with bladder cancer that has spread to other organs. To qualify, patients must have specific genetic changes in their tumors. Currently, doctors use tumor tissue samples to check for these genetic changes, but these samples might not accurately reflect the current state of the patient's cancer. In this study, Investigators will test the patient's blood for these genetic changes in addition to the tumor tissue samples. It is thought that the blood test will give a more accurate result. Investigators hope this study will help to find out if more patients can benefit from erdafitinib than the ones identified by tissue testing only.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Urothelial Carcinoma | Urothelial Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FGFR Testing | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Metastatic Bladder Cancer
- description
- Patients with metastatic bladder cancer who will have archival tissue sent for FGFR testing.
- interventionNames
- Genetic: FGFR Testing
Primary outcomes (1)
- measure
- To evaluate the diagnostic value of ctDNA testing against standard tissue testing
- timeFrame
- For the primary objective, a single blood sample is collected at the time of screening for treatment eligibility
- description
- Investigators will evaluate ctDNA as a diagnostic test against the de facto gold standard of tissue testing.
Secondary outcomes (1)
- measure
- To evaluate whether ctDNA may be a superior predictive marker by identifying actionable FGFR mutations that are currently missed on tissue assays
- timeFrame
- For this secondary objective, a single blood sample is collected at the time of screening for treatment eligibility
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDKnowles MA, Hurst CD. Molecular biology of bladder cancer: new insights into pathogenesis and clinical diversity. Nat Rev Cancer. 2015 Jan;15(1):25-41. doi: 10.1038/nrc3817. PMID 25533674
- BACKGROUNDLoriot Y, Necchi A, Park SH, Garcia-Donas J, Huddart R, Burgess E, Fleming M, Rezazadeh A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Zhong B, Stuyckens K, Santiago-Walker A, De Porre P, O'Hagan A, Avadhani A, Siefker-Radtke AO; BLC2001 Study Group. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2019 Jul 25;381(4):338-348. doi: 10.1056/NEJMoa1817323. PMID 31340094