NCT06129084

A Study to Compare the Results of FGFR Testing by Either ctDNA Blood Testing or Standard Tumor Tissue Testing

Active, enrolled Last updated 15 December 2025

What this trial tests

trial testing FGFR Testing in Metastatic Bladder Cancer in 260 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 January 2021

Primary endpoint
15 September 2025

31 December 2026

Quick facts

Lead sponsor	Bernie Eigl
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	260
Start date	11 January 2021
Primary completion	15 September 2025
Estimated completion	31 December 2026
Sites	7 locations across Canada

Drugs / interventions tested

• FGFR Testing

Conditions studied

• Metastatic Bladder Cancer — all drugs for Metastatic Bladder Cancer →
• Metastatic Urothelial Carcinoma — all drugs for Metastatic Urothelial Carcinoma →

Sponsor

Bernie Eigl

Who can join

18 and older, any sex, with Metastatic Bladder Cancer or Metastatic Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Plasma-Derived Cell-Free DNA as a Biomarker for Early Detection, Prognostication, and Personalized Treatment of Urothelial Carcinoma.
   Bhalla S, Passarelli R, Biswas A, De S, et al · · 2024 · cited 10× · PMID 38610824 · DOI 10.3390/jcm13072057
2. FGFR Inhibitors in Urothelial Cancer: From Scientific Rationale to Clinical Development.
   Kwon WA. · · 2024 · cited 4× · PMID 39536791 · DOI 10.3346/jkms.2024.39.e320
3. Longitudinal assessment of health-related quality of life in Japanese patients with advanced urothelial carcinoma receiving immune check point inhibitors.
   Miyake M, Nishimura N, Oda Y, Miyamoto T, et al · · 2024 · cited 3× · PMID 39367041 · DOI 10.1038/s41598-024-72755-8
4. Prospective multicenter study of ctDNA versus tumor tissue guiding FGFR-targeted therapy in metastatic urothelial cancer.
   Müller DC, Murtha AJ, Bacon JVW, Stephenson M, et al · · 2026 · cited 1× · PMID 41760649 · DOI 10.1038/s41467-026-69927-7