Brief Title
Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib
Official Title
Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib
Brief Summary
Bladder cancers are associated with genetic mutations that are present in the patient's
bladder or urothelium, the lining of the lower urinary tract. Fibroblast growth factor (FGFR)
alterations are present in approximately one in five patients with recurrent and refractory
bladder cancer.
This study will collect biomarker data from subjects receiving erdafitinib to further
investigate the relationship between treatment with erdafitinib and clinical response,
progression, and/or genetic alterations.
Detailed Description
The purpose of this study is to collect biomarker data from subjects receiving standard of
care erdafitinib to further investigate the relationship between treatment with erdafitinib
and clinical response, progression, and/or genetic alterations in cell free tumor DNA (cfDNA)
from blood and urine samples.
In this study, next generation sequencing of cfDNA isolated from blood and urine will be
performed by Resolution Bioscience. Blood-based cfDNA amplification and analysis is done by a
CLIA-approved assay and the results of which will thus be available to physicians and
patients. Urine-based cfDNA analysis from Resolution Bioscience is not yet approved and
results will only be communicated if an actionable finding is identified that is not present
on the blood-based test. Samples will be collected at the patients homes by a qualified
phlebotomist.
xCures may provide the treating physician and the subject the biomarker results from
blood-based cfDNA tests. Because the testing of urine DNA is experimental and done solely for
research, those results will not be shared unless there is an important finding known to be
relevant to the subject's medical care at the time of the study. The genetic tests are not
approved for bladder cancer, so the information generated from biomarker research studies is
preliminary in nature. Therefore, the significance and scientific validity of the results are
undetermined. xCures and/or Tyra may additionally share data with the treating physician and
researchers for the purposes of publication.
Patients co-enroll in an observational research study (XCELSIOR, NCT03793088) and consent to
provide xCures right of access to their full medical records under HIPAA.
Patient clinical data is structured and centralized by xCures in a 21 CFR Part 11-compliant
REDCap Cloud database in Case Report Forms (CRFs). The CRFs are a set of electronic forms for
each patient that provides a record of clinical data generated according to the protocol.
Data is abstracted directly from medical records generated in the standard practice of
medicine.
xCures will request medical records directly from treating institutions and from other
providers (commercial next generation sequencing providers, for example) and will work with
treating physicians to ensure the completeness and accuracy of CRF content based on
electronic medical records.
Study Type
Observational
Primary Outcome
Relationship between treatment with erdafitinib and clinical response
Condition
Bladder Cancer
Intervention
Balversa
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
50
Start Date
September 2021
Completion Date
August 2022
Primary Completion Date
August 2022
Eligibility Criteria
Inclusion Criteria:
- Subjects with a diagnosis of locally advanced or metastatic bladder caner
- Documented proof of an FGFR alteration according to a CLIA-based test
- Subjects who are receiving or will receive erdafitinib as their standard medical
therapy as a monotherapy or in combination
- Age greater than or equal to 18 years.
- Subject is a resident of or seeking care in the United States
- Able and willing to provide informed consent to this biomarker study
- Informed consent obtained for the XCELSIOR longitudinal outcomes registry
(NCT03793088).
Exclusion Criteria:
- Subjects younger than 18 years of age
- Subjects unwilling or unable to provide informed consent
- Subjects that are not receiving treatment in the United States or US Territories
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Daniel J. George, MD, (707) 641-4475, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05052372
Organization ID
TYRA-001-BC-2021
Responsible Party
Sponsor
Study Sponsor
xCures
Study Sponsor
Daniel J. George, MD, Principal Investigator, Duke Health
Verification Date
September 2021