Study
NLST
(Learn more about this study)
Project ID
NLST-1360
Initial CDAS Request Approval
Nov 21, 2024
Title
A nested case-control study from NLST to evaluate a multiplex protein biomarker-based immunoassay for the early detection of bladder cancer
Summary
When detected early bladder cancer has a 5-yr survival rate is >90%, compared to a significant reduction in survival if the disease is noted to be MIBC (stage 2; 50% 5-yr survival) or metastatic (stages 3 and 4; <20% 5-yr survival). Thus, the prevailing idea is that early detection of bladder cancer in high risk individuals (i.e., individuals exposed to certain carcinogens) will likely be the best modality to address advanced bladder cancer’s dismal outcomes. Currently, the evaluation of at risk individuals remains a challenge, and as such, there are no modalities available to effectively screen this high risk population. Previously, we have a) identified a bladder cancer-associated diagnostic “signature” comprised of 10 biomarkers, b) developed a multiplex immunoassay to query the “signature” in voided urine samples and c) performed analytical and clinical validation of the multiplex immunoassay (AUC 0.95; sensitivity 0.93, specificity 0.93). Thus, for the first time, we possess a robust assay that can be used to non-invasively detect bladder cancer. Now, we have evidence from a nested case-control study of ~550 subjects from SWHS, SMHS, SCCS, MEC and SCHS that 9 of our 10 biomarkers within the “signature” are significantly elevated in cases vs. controls 12-24 months prior to developing bladder cancer. Hypothesis: A bladder cancer signature exists that can be leveraged to indicate the presence of bladder cancer from a single voided urine sample months to years prior to the clinical presentation bladder cancer. Significance This research will open the door for improving on the non-invasive methods for the early detection of bladder cancer, and as such, it will have a marked impact on patient survival. Methodology We will retrospectively analyze serial voided urine samples from patients who developed bladder cancer on NLST with our multiplex immunoassay and compare the results to matched controls from NLST.
Aims
To evaluate a multiplex immunoassay’s ability to detect a bladder cancer-associated diagnostic “signature” in voided urine samples from patients at risk of developing bladder cancer with the expressed goal of the early detection of bladder cancer.
Current markers being tested include the 10 protein based urinary biomarkers that comprise the bladder cancer-associated diagnostic “signature”; ANG, APOE, A1AT, CA9, IL8, MMP9, MMP10, PAI1, SDC1, and VEGF.
Collaborators
Name: Hideki Furuya
Suffix (e.g., M.D., Ph.D.): Ph.D
Institution: Cedars-Sinai Medical Center
State, Country: CA, USA
Email: Hideki.furuya@cshs.org
Network Group affiliation (if any): SWOG
Name: Ian Pagano (primary statistician)
Suffix (e.g., M.D., Ph.D.): PhD
Institution: University of Hawaii Cancer Center
State, Country: Hawaii, USA
Email: pagano@hawaii.edu
Network Group affiliation (if any): NCORP
