Metastatic Bladder CancerNCT06129084
A Study to Compare the Results of FGFR Testing by Either ctDNA Blood Testing or Standard Tumor Tissue Testing
An observational study of Metastatic Bladder Cancer and Metastatic Urothelial Carcinoma, run by Bernie Eigl at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Bladder Cancer, Metastatic Urothelial Carcinoma
- What is being tested?
- FGFR Testing
- How many people
- 260 participants
- Where
- 7 sitesCanada
- Study dates
- 11 Jan 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic urothelial cancer who are screened for erdafitinib eligibility as standard of care.
Who may be able to join
- 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.
Who cannot join
- Metastatic bladder cancer patients who will not have tissue sent for FGFR testing will be excluded from this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Arthur J.E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
London Health Sciences Centre
London, Ontario, N6A 5W9
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
CHU de Québec-Université Laval
Québec, Quebec, G1R 2J6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: ctDNA-FGFR Status as a Predictive Biomarker for FGFR Targeted Therapy
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.
Read the 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.
- Being tested
- FGFR Testing
- Keywords
- ctDNA-FGFR, FGFR Biomarker, Erdafitinib
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGFR TestingGenetic
Determine whether ctDNA testing for FGFR provides the same results as the standard tissue testing.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Bladder Cancer | Patients with metastatic bladder cancer who will have archival tissue sent for FGFR testing. Receives: Genetic: FGFR Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: For this secondary objective, a single blood sample is collected at the time of screening for treatment eligibility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start11 Jan 2021
- Primary completion15 Sep 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernie Eigl
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Prostate Centre, Lady Davis Institute, Bladder Cancer Canada
- Responsible party
- Sponsor-investigator, Bernie Eigl, British Columbia Cancer Agency
- Investigators
- Bernhard Eigl, Study chair, British Columbia Cancer AgencyAlexander Wyatt, Study chair, Vancouver Prostate Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129084
- Sponsor's protocol ID
- ctDNA FGFR
- Status last verified
- Dec 2025
- First submitted
- 8 Nov 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plans for future use of the data at this point. Only the study Principal Investigator will have access to the data in the future.
Publications
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.
PubMed 25533674Loriot 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.
PubMed 31340094
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ctDNA-FGFR Status as a Predictive Biomarker for FGFR Targeted Therapy
- ClinicalTrials.gov ID
- NCT06129084
- Acronym / sponsor ID
- ctDNA FGFR
- Keywords
- ctDNA-FGFR, FGFR Biomarker, Erdafitinib
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Bernie EiglUniversity, hospital or other
- Collaborators
- Vancouver Prostate Centre, Lady Davis Institute, Bladder Cancer Canada
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Bladder Cancer | – | Genetic: FGFR TestingPatients with metastatic bladder cancer who will have archival tissue sent for FGFR testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic urothelial cancer who are screened for erdafitinib eligibility as standard of care.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Metastatic bladder cancer patients who will not have tissue sent for FGFR testing will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FGFR TestingDetermine whether ctDNA testing for FGFR provides the same results as the standard tissue testing. | Genetic | Metastatic Bladder Cancer |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 25533674Knowles 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.
- Background: PubMed 31340094Loriot 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.
- Individual participant dataSharing planned: Undecided. No plans for future use of the data at this point. Only the study Principal Investigator will have access to the data in the future.
Related trials for Metastatic Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruiting
An Education and Navigation Support Tool to Improve Participation in Care Coordination Among Patients With Locally Advanced, Metastatic and Unresectable Bladder Cancer and Their Caregivers
Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma
Not yet recruitingPhase 1
DV Plus Toripalimab With Cetirizine and Mecobalamin Pretreatment in Patients With Locally Advanced Unresectable or Metastatic Bladder Cancer
Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Eigl study chair
British Columbia Cancer Agency
Alexander Wyatt study chair
Vancouver Prostate Centre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Bladder Cancer and Metastatic Urothelial Carcinoma, run by Bernie Eigl at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06129084, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.