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Active, Not Recruiting

NCT Number: NCT06129084

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Metastatic Bladder Cancer Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Metastatic Urothelial Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arthur J.E Child Comprehensive Cancer Centre, Calgary, Alberta, Canada

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About this study

Recently, the first targeted therapy for patients with metastatic urothelial cancer (mUC) received approval, i.e. erdafitinib. Erdafitinib is a pan-FGFR small molecule inhibitor. Approximately twenty percent of mUC patients' tumors harbor qualifying alterations in FGFR2 or FGFR3. Currently, standard testing uses archival tumor tissue. However, this type of testing may not be representative of a patient's clinically dominant tumor clone at the time of treatment initiation due to temporal and spatial biopsy bias of archival tissue testing.

In this study, patients will undergo circulating tumor DNA testing, in addition to conventional tissue testing, for treatment eligibility. Investigators hypothesize that blood-based ctDNA testing will provide a more accurate assessment of somatic FGFR status than same patient archival primary tissue.

This study's objectives are:

Objective 1 (Primary): To evaluate the diagnostic value of ctDNA testing against the "gold standard" of tissue testing.

Objective 2 (Secondary): To evaluate whether ctDNA may be a superior predictive marker by identifying actionable FGFR alterations that are currently missed on tissue assays.

Procedures:

  • Medical history will be reviewed, including all previous anti-cancer treatments.
  • A blood sample will be collected for ctDNA testing at the time of screening for FGFR alterations and at progression under erdafitinib therapy. Test results will be compared to archival tissue testing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FGFR Testing

Genetic

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

Primary outcomes

  1. To evaluate the diagnostic value of ctDNA testing against standard tissue testing

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

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

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

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

    To quantify the additional value of ctDNA testing, Investigators will calculate the percentage of eligible patients based on ctDNA testing among conventional testing ineligible or "negative" patients.

Sponsors and collaborators

Lead sponsor

Bernie Eigl

Other

Collaborators

  • Bladder Cancer Canada
  • Lady Davis Institute
  • Vancouver Prostate Centre

Registry information

Official study title

ctDNA-FGFR Status as a Predictive Biomarker for FGFR Targeted Therapy

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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