Bladder CancerNCT04339933
Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma
An observational study of Bladder Cancer, run by Ho Kyung Seo.
Trial summary
This study aims to compare the correlation between FGFR mutations found in bladder cancer tissues and urine to develop a companion diagnostic method for predicting the effect of FGFR inhibitors using urine samples of the patients with urothelial cancer. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- FGFR test
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suspected patients of urothelial cancer who will visit the National Cancer Center Korea.
Who may be able to join
- Suspected patients of urothelial cancer who will visit the National Cancer Center Korea from the date of Institutional Review Board (IRB) approval to 2021 and with identified tumors in the bladder according to bladder endoscopy.
- Subjects who are scheduled for surgery (transurethral bladder tumor resection, radical bladder resection, and radical bladder ureterectomy) and have agreed to participate in the study
Who cannot join
- History of other active malignant tumors treated within 24 months
- Patients with either mental illness or who cannot participate in clinical trials at the judgment of other doctors
- If patients and guardians do not want to participate in this study
- History of having administered FGFR inhibitors in the past
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to compare the correlation between FGFR mutations found in bladder cancer tissues and urine to develop a companion diagnostic method for predicting the effect of FGFR inhibitors using urine samples of the patients with urothelial cancer.
Read the detailed description
This study targets 92 patients with urothelial cancer, whose tissue (from scheduled surgery) and urine samples can be obtained, regardless of the treatment stage.
■ Examination Methods
- FGFR mutations in bladder cancer tissues will be analyzed using next-generation sequencing and current companion diagnostic methods.
- FGFR mutations in urine samples obtained from patients with bladder cancer will be analyzed using nanowires.
- Bladder cancer subtyping will be performed by RNA sequencing of tumor tissues or other methods.
- Analysis of paired tissues before and after chemotherapy will be performed on transurethral resection of bladder tumor (TUR-BT) and cystectomy tissues before and after neoadjuvant chemotherapy.
- Conditions
- Bladder Cancer
- Being tested
- FGFR test
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGFR testDiagnostic test
Detection of FGFR gene mutations in the tumor tissue and urine of patients
| Study group | Role | What they receive |
|---|---|---|
| BC | Patients who were diagnosed with bladder cancer Receives: Diagnostic Test: FGFR test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between FGFR mutations found in bladder cancer tissues and urine before and after treatment
The ratio of patients with matching test results to total patients
Measured: Up to two weeks before and after surgery
Secondary outcomes (6)
Changes in FGFR mutations in tissues before and after treatment
Changes in FGFR mutations in tissues before and after treatment will be observed in the patients with muscle-invasive and non-muscle-invasive bladder cancer undergoing neoadjuvant chemotherapy and transurethral bladder tumor resection, respectively, due to recurrence.
Measured: Up to two weeks before and after treatment
Patient prognosis
recurrence-free
Measured: six months and one year after treatment
Patient prognosis
progression-free
Measured: six months and one year after treatment
Patient prognosis
cancer-specific survivals
Measured: six months and one year after treatment
Patient prognosis
overall survivals
Measured: six months and one year after treatment
PD-L1 expression
PD-L1 expression level will be measured using immunohistochemistry, RNA sequencing, and other suitable methods to analyze the bladder cancer subtypes
Measured: Up to two weeks before and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 May 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ho Kyung Seo
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ho Kyung Seo, National Cancer Center, Korea
- Investigators
- Ho Kyung Seo, MD, PhD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339933
- Sponsor's protocol ID
- U-FGFR
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cancer Genome Atlas Research Network. Comprehensive molecular characterization of urothelial bladder carcinoma. Nature. 2014 Mar 20;507(7492):315-22. doi: 10.1038/nature12965. Epub 2014 Jan 29.
PubMed 24476821Loriot 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 31340094Wu YM, Su F, Kalyana-Sundaram S, Khazanov N, Ateeq B, Cao X, Lonigro RJ, Vats P, Wang R, Lin SF, Cheng AJ, Kunju LP, Siddiqui J, Tomlins SA, Wyngaard P, Sadis S, Roychowdhury S, Hussain MH, Feng FY, Zalupski MM, Talpaz M, Pienta KJ, Rhodes DR, Robinson DR, Chinnaiyan AM. Identification of targetable FGFR gene fusions in diverse cancers. Cancer Discov. 2013 Jun;3(6):636-47. doi: 10.1158/2159-8290.CD-13-0050. Epub 2013 Apr 4.
PubMed 23558953
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of FGFR Gene Mutations in the Tumor Tissue and Urine of Patients With Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04339933
- Acronym / sponsor ID
- U-FGFR
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Ho Kyung SeoOther government
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 9 Apr 2020 (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.
This study aims to compare the correlation between FGFR mutations found in bladder cancer tissues and urine to develop a companion diagnostic method for predicting the effect of FGFR inhibitors using urine samples of the patients with urothelial cancer.
Detailed description
This study targets 92 patients with urothelial cancer, whose tissue (from scheduled surgery) and urine samples can be obtained, regardless of the treatment stage.
■ Examination Methods
- FGFR mutations in bladder cancer tissues will be analyzed using next-generation sequencing and current companion diagnostic methods.
- FGFR mutations in urine samples obtained from patients with bladder cancer will be analyzed using nanowires.
- Bladder cancer subtyping will be performed by RNA sequencing of tumor tissues or other methods.
- Analysis of paired tissues before and after chemotherapy will be performed on transurethral resection of bladder tumor (TUR-BT) and cystectomy tissues before and after neoadjuvant chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BC | – | Diagnostic Test: FGFR testPatients who were diagnosed with bladder cancer |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected patients of urothelial cancer who will visit the National Cancer Center Korea.
Key inclusion criteria (2 listed)
- Suspected patients of urothelial cancer who will visit the National Cancer Center Korea from the date of Institutional Review Board (IRB) approval to 2021 and with identified tumors in the bladder according to bladder endoscopy.
- Subjects who are scheduled for surgery (transurethral bladder tumor resection, radical bladder resection, and radical bladder ureterectomy) and have agreed to participate in the study
Key exclusion criteria (4 listed)
- History of other active malignant tumors treated within 24 months
- Patients with either mental illness or who cannot participate in clinical trials at the judgment of other doctors
- If patients and guardians do not want to participate in this study
- History of having administered FGFR inhibitors in the past
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 testDetection of FGFR gene mutations in the tumor tissue and urine of patients | Diagnostic test | BC |
Primary outcome
Correlation between FGFR mutations found in bladder cancer tissues and urine before and after treatment
Time frame: Up to two weeks before and after surgery
The ratio of patients with matching test results to total patients
6 secondary outcomes
Changes in FGFR mutations in tissues before and after treatment
Time frame: Up to two weeks before and after treatment
Patient prognosis
Time frame: six months and one year after treatment
Patient prognosis
Time frame: six months and one year after treatment
Patient prognosis
Time frame: six months and one year after treatment
Patient prognosis
Time frame: six months and one year after treatment
PD-L1 expression
Time frame: Up to two weeks before and after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Background: PubMed 24476821Cancer Genome Atlas Research Network. Comprehensive molecular characterization of urothelial bladder carcinoma. Nature. 2014 Mar 20;507(7492):315-22. doi: 10.1038/nature12965. Epub 2014 Jan 29.
- 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.
- Background: PubMed 23558953Wu YM, Su F, Kalyana-Sundaram S, Khazanov N, Ateeq B, Cao X, Lonigro RJ, Vats P, Wang R, Lin SF, Cheng AJ, Kunju LP, Siddiqui J, Tomlins SA, Wyngaard P, Sadis S, Roychowdhury S, Hussain MH, Feng FY, Zalupski MM, Talpaz M, Pienta KJ, Rhodes DR, Robinson DR, Chinnaiyan AM. Identification of targetable FGFR gene fusions in diverse cancers. Cancer Discov. 2013 Jun;3(6):636-47. doi: 10.1158/2159-8290.CD-13-0050. Epub 2013 Apr 4.
- Individual participant dataSharing planned: Undecided
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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.
Ho Kyung Seo, MD, PhD principal investigator
National Cancer Center, Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Ho Kyung Seo.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho Kyung Seo, MD, PhD (+82-31-920-1678, seohk@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between FGFR mutations found in bladder cancer tissues and urine before and after treatment (time frame: Up to two weeks before and after surgery). 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 NCT04339933, which also lists 3 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 7 Apr 2022.