Our proposal is in keeping with the objectives of the RFA to continue the excellent ongoing studies of the consortium (CPDPC) to study the relationship between Chronic Pancreatitis (CP), Diabetes (DM) and Pancreatic Cancer (PDAC). The Principal Investigators of this proposal (Drs. Chari and Maitra, both currently based at UT MD Anderson Cancer Center, UTMDACC) have played key and substantial roles in the first cycle of the CPDPC. First, they have served as co-leaders of the DM-PDAC working group, which has been responsible for the design and conduct of the ongoing NOD study, which was inspired by a series of seminal observations made by Dr. Chari in the 2000s. Second, Dr. Maitra has served as Co-PI of the Data Management and Coordination Center (DMCC) of the CPDPC, which provides him with extensive familiarity with the inner workings of data management and oversight required for accrual to NOD and other prospective cohorts. Third, Dr. Chari was previously the site Co-PI of Mayo Clinic site, which has contributed to all aspects of CPDPC in the last cycle. From the experience of the past 4.5 years, it is clear that successful recruitment of subjects to these studies requires a mix of tertiary care hospitals (for PROCEED and DETECT cohorts), combined with access to large primary care healthcare systems with integrated electronic medical record systems, information technology (IT) support and infrastructure (for the NOD study). To this end, an Alliance of Texas and Louisiana investigators and institutions overseen by the PIs at UTMDACC will recruit to ongoing CPDPC cohort studies. In addition, we propose 6 ancillary studies that are ideally suited for performance by a collaborative consortium and significantly advance our understanding of the interconnected pathologies of CP, PDAC and DM. In accordance with the RFA, the Specific Aims of our proposal are to:
Aim 1 a) Recruit subjects for PROCEED study: This will occur at the University of Texas Health Sciences Center, Houston (UTHSC-H) and Memorial Hermann Health System, both large volume gastroenterology practices that are well positioned to recruit patients for the PROCEED Study. b) Recruit subjects for the DETECT study: The UTHSC-H will recruit patients for DETECT study c) Recruit subjects for the NOD Study: The recruitment will occur through the Ochsner Clinic, Louisiana, a large, integrated primary health system in Louisiana, which is also highly enriched for underrepresented minority population of African Americans, who are known to harbor a preponderance of both DM and PDAC.
Aim 2) Perform a series of innovative ancillary studies to examine the association among CP, DM and PDAC: 6 such studies are outlined in this proposal.
This proposal aims to recruit a large and ethnically diverse population of subjects from Texas and Louisiana for the ongoing studies of the consortium (CPDPC) to study Chronic Pancreatitis (CP), Diabetes (DM) and Pancreatic Cancer (PDAC) launched by the collaborative efforts of NIDDK and NCI. To effectively contribute to the ongoing CPDPC clinical studies, we have assembled a team of researchers and clinicians (gastroenterologists, endocrinologists and internists) from tertiary and primary care centers to effectively accomplish the goals of the CPDPC. Additionally, we propose six innovative ancillary study concepts that will deepen our understanding of the connection between DM, PDAC and CP and facilitate the identification of subjects with PDAC among subjects with new onset DM.
