MC240508: Genomic Surveillance Of Bladder Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 25-000782
Sponsor Protocol Number: MC240508
About this study
The purpose of this study is to build a comprehensive genomic repository that details the evolution of bladder cancer. By employing WGS-based ctDNA approach testing using Veracyte, the study seeks to better understand tumor behavior, mechanisms of treatment resistance, and predictive biomarkers of response. This repository will aid in elucidating the relationship between tumor genomics and clinical outcomes, providing insights that can inform the development of personalized therapeutic strategies. This is a prospective, exploratory biomarker study that will enroll subjects who have undergone prior biopsy, with available formalin-fixed paraffin-embedded (FFPE) tissue specimens. The study incorporates baseline and follow-up ctDNA assessments to monitor molecular residual disease (MRD) through a tumor-informed WGS-based ctDNA approach developed by Veracyte.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Subjects will be screened for eligibility based on inclusion and exclusion criteria. This will involve reviewing medical records, pathology reports, and diagnostic imaging to confirm the diagnosis of bladder cancer.
Exclusion Criteria:
This study will exclude children, prisoners, pregnant women, fetuses, neonates, and adults lacking capacity to consent (unless a legally authorized representative is available and willing to consent on their behalf). Patients with insufficient tissue or plasma samples for analysis.
Vulnerable Groups: While the study does not specifically target vulnerable populations, it does not exclude them based on socio-economic or educational status. Special provisions will be made to ensure informed consent is understood and voluntary, with accommodations provided for non-English speakers, individuals who are unable to read, or those who may be educationally or financially disadvantaged.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/20/2025. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Parminder Singh, M.D. |
Closed-enrolling by invitation |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available