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

NCT06129084 | Active Not Recruiting

• 1 other identifier: ctDNA FGFR
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 7

Brief Summary

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

Metastatic Bladder Cancer; Metastatic Urothelial Carcinoma

Keywords

ctDNA-FGFR; FGFR Biomarker; Erdafitinib

Outcome Measures

Primary Outcomes (1)

• To evaluate the diagnostic value of ctDNA testing against standard tissue testing

  Investigators will evaluate ctDNA as a diagnostic test against the de facto gold standard of tissue testing.

  For the primary objective, a single blood sample is collected at the time of screening for treatment eligibility

Secondary Outcomes (1)

• To evaluate whether ctDNA may be a superior predictive marker by identifying actionable FGFR mutations that are currently missed on tissue assays

  For this secondary objective, a single blood sample is collected at the time of screening for treatment eligibility

Study Arms (1)

Metastatic Bladder Cancer

Patients with metastatic bladder cancer who will have archival tissue sent for FGFR testing.

Genetic: FGFR Testing

Interventions

FGFR Testing GENETIC

Determine whether ctDNA testing for FGFR provides the same results as the standard tissue testing.

Metastatic Bladder Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic urothelial cancer who are screened for erdafitinib eligibility as standard of care.

You may qualify if:

• 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.

You may not qualify if:

• Metastatic bladder cancer patients who will not have tissue sent for FGFR testing will be excluded from this study.

Sponsors & Collaborators

• Bernie Eigl: lead
• Vancouver Prostate Centre: collaborator
• Lady Davis Institute: collaborator
• Bladder Cancer Canada: collaborator

Study Sites (7)

Arthur J.E Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

CHU de Québec-Université Laval

Québec, Quebec, G1R 2J6, Canada

Location

Related Publications (2)

• Knowles 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 BACKGROUND

• Loriot 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma ctDNA and archival tumour tissue will be tested for FGFR status.

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Bernhard Eigl

  British Columbia Cancer Agency

  STUDY CHAIR

• Alexander Wyatt

  Vancouver Prostate Centre

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: January 11, 2021
• Primary Completion: September 15, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CA (7)