Trial Title:
A Study to Compare the Results of FGFR Testing by Either CtDNA Blood Testing or Standard Tumor Tissue Testing
NCT ID:
NCT06129084
Condition:
Metastatic Bladder Cancer
Metastatic Urothelial Carcinoma
Conditions: Official terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Conditions: Keywords:
ctDNA-FGFR
FGFR Biomarker
Erdafitinib
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Genetic
Intervention name:
FGFR Testing
Description:
Determine whether ctDNA testing for FGFR provides the same results as the standard tissue
testing.
Arm group label:
Metastatic Bladder Cancer
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
Patients with metastatic urothelial cancer who are screened for erdafitinib eligibility
as standard of care.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arthur J.E Child Comprehensive Cancer Centre
Address:
City:
Calgary
Zip:
T2N 5G2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Clinical Research Coordinator
Email:
Oladayo.Olaleye@albertahealthservices.ca
Contact backup:
Last name:
Nimira Alimohamed
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Project Manager
Email:
Kathryn.Rankin@albertahealthservices.ca
Contact backup:
Last name:
Naveen Basappa
Facility:
Name:
BC Cancer Agency
Address:
City:
Vancouver
Zip:
V5Z 4E6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Clinical Research and Trials Coordinator
Email:
lisa.rebane@bccancer.bc.ca
Contact backup:
Last name:
Bernie Eigl
Facility:
Name:
London Health Sciences Centre
Address:
City:
London
Zip:
N6A 5W9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Email:
Kathie.Baer@lhsc.on.ca
Contact backup:
Last name:
Eric Winquist
Facility:
Name:
Ottawa Hospital Research Institute
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Email:
sgrimes@toh.ca
Contact backup:
Last name:
Michael Ong
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Clinical Research Study Assistant
Email:
Jenny.Su@uhn.ca
Contact backup:
Last name:
Srikala Sridhar
Facility:
Name:
CHU de Québec-Université Laval
Address:
City:
Québec City
Zip:
G1R 2J6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Research Coordinator
Email:
Carole.Plante@crchudequebec.ulaval.ca
Contact backup:
Last name:
Paul Toren
Start date:
January 11, 2021
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Bernie Eigl
Agency class:
Other
Collaborator:
Agency:
Vancouver Prostate Centre
Agency class:
Other
Collaborator:
Agency:
Lady Davis Institute
Agency class:
Other
Collaborator:
Agency:
Bladder Cancer Canada
Agency class:
Other
Source:
British Columbia Cancer Agency
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06129084
