Abstract 1547P
Background
Delayed diagnosis and rapid progression drive poor survival outcomes for PDAC. Project Survival® is a multicenter (n=6), prospective study (NCT 02781012) of PDAC and relevant controls combining high-fidelity phenotypic characterization, multi-omic profiling, and Bayesian network artificial intelligence to discover candidate diagnostic and therapeutic biomarkers.
Methods
Biorepository protocols complied with NCI BRISQ guidelines (Tier 1: 93%; Tier 2: 89%; Tier 3: 82%) and SPREC coding (100%). Clinical data were organized and curated using simplified CDISC classifiers. Data integrity was ensured by central pathology and radiologic analyses, multilevel specimen quality assessment, and auditing procedures according to standardized clinical trial definitions and outcomes.
Results
The PDAC cohort consisted of 52 early stage (median Ca19-9 25 [IQR 104] IU/ml), 112 locally advanced (Ca19-9 59[372]), and 138 metastatic patients (Cal9-9 200[2339]) having 2 median study visits (IQR 3, range 1-12). 470,000 clinical data points were amassed to characterize the longitudinal evolution of PDAC and relevant pancreatic disease controls across 822 clinical variables per visit. Tumor characteristics included: primary location (head 64%, body/tail 28%), vascular involvement (62%), regional adenopathy (12%), and distant metastases to peritoneum (3.7%), lung (8.8%), and liver (23.3%). Table: 1547P
| Characteristic | PDAC (n=302) | Entire Cohort (n=452) |
| Age, yrs (IQR) | 67 (13) | 66 (15) |
| Sex, male, % | 55% | 53% |
| Af Am, Jewish, White, Other % | 5.0%, 6.3%, 92.1%, 6% | 5.2%, 7.2%, 92.4%, 5.9% |
| Pancreatitis hx, % | 17% | 22% |
| Diabetes, % | 28% | 26% |
| Family History PDAC % | 17% | 22% |
| Pain % | 38% | 33% |
| Weight Loss, lbs. median (IQR) | 8.0 (7.9) | 7.7 (8.3) |
Conclusions
Interrogative Biology® platform analytics was employed to infer causal relationships between existing pancreatic cancer therapies and longitudinal alterations in the proteomic, metabolomic, and lipidomic responses to 253 treatment interventions and 211 progression events. We believe this cohort to be the largest high-fidelity pan-omic characterization of pancreatic cancer and its risk factors..
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
BERG LLC.
Funding
BERG LLC.
Disclosure
A.J. Moser, C.L. DeCicco, K. Schawkat, G.L. Perez-Melara: Research grant/Funding (institution): BERG LLC. M.A. Kiebish, E.M. Grund, N.M. Chand: Full/Part-time employment: BERG LLC. G.M. Miller, L.O. Rodrigues, E. Granger, R. Sarangarajan, N.R. Narain: Full/Part-time employment: BERG LLC.