Welcome to the
Chronic Pancreatitis
Clinical Research Consortium
(CPCRC)
Welcome to the
Study of Chronic Pancreatitis, Diabetes and
Pancreatic Cancer (CPDPC)
Research Consortia
Research Objective
The overriding two objectives of this research program are to pursue clinical research on Chronic Pancreatitis (including those with Acute Recurrent Pancreatitis, ARP), by identifying and characterizing a large cohort of pediatric and adult patients with CP and ARP to encourage translational research focusing upon elucidating the pathogenesis that will provide the basis for understanding the natural history and developing means of diagnosis, treatment and clinical management of Chronic Pancreatitis and its sequela: chronic pain, pancreatic insufficiency and on pancreatic cancer and pancreatogenic Diabetes Mellitus (T3cDM) and their pathogenic interrelationships, by identifying and following a cohort of newly diagnosed diabetic patients in the setting of Cancer Prevention.
Research results are shared freely within the consortium to develop trans-consortium collaborative projects that make use of the combined expertise and technological capabilities present in all of the Clinical Centers.
The Chronic Pancreatitis Clinical Research Consortium (CPCRC) was formed to undertake a comprehensive clinical, epidemiological, and biological characterization of patients with Chronic Pancreatitis (including those with Acute Recurrent Pancreatitis, ARP) to gain insight into the pathophysiology of chronic pancreatitis and its sequela: chronic pain, pancreatic insufficiency, T3cDM and the diabetes/pancreatic cancer association.
The multidisciplinary teams will also undertake studies on the development of pancreatic cancer in newly diagnosed diabetic patients.
On Chronic Pancreatitis (including those with Acute Recurrent pancreatitis, ARP), by identifying and characterizing a large cohort of pediatric and adult patients with CP and ARP to encourage translational research focusing upon elucidating the pathogenesis that will provide the basis for understanding the natural history and developing means of diagnosis, treatment and clinical management of Chronic Pancreatitis and its sequela: chronic pain, pancreatic insufficiency and on pancreatic cancer and pancreatogenic Diabetes Mellitus (T3cDM) and their pathogenic interrelationships, by identifying and following a cohort of newly diagnosed diabetic patients in the setting of Cancer Prevention.
Research and Initiatives
Grantor Organizations
The National Institutes of Health (NIH) distributes funding to the following organizations through congressional appropriations. The organization's leadership, guided by the mission set by the nation's scientists, evaluates applications and grants funds to organizations with the mission, goals, expertise and resources to carry out the research initiatives set forth by the needs of the American People and the World for cancer research.
Awardee Organizations
Our consortium comprises the following organizations, which have been awarded research programs by the National Cancer Institute (NCI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), both funded by the National Institutes of Health (NIH) through appropriations budgeted by the United States Congress.
Learn more about each awardee organization, the Principal Investigators, and their research teams contributing to the Consortium for the Chronic Pancreatitis Clinical Research Consortium (CPCRC).
Participating Cohort Organizations
In every multi-site research consortium, participating cohort organizations are very crucial to the overall success of the research. These organizations lend their leadership, expertise, and resources to support the specific aims of the various research centers, workgroups, and studies. Additionally, many contribute significantly to the leadership of the consortium by participating in committees that drive the various activities and initiatives.
Learn more about the participating cohort organizations contributing significantly to the research efforts associated with the Chronic Pancreatitis Clinical Research Consortium (CPCRC).
Multi-site research projects are essential within cancer research to help drive discovery when advancing medical treatments. Although the success of multi-site research is significantly dependent on clinical and organizational expertise, management, best practices for engagement, and data security is an essential part of research coordination.
The Coordinating and Data Management Centers (CDMCs) play a crucial role in managing and coordinating multi-site research projects funded by the National Institutes of Health (NIH). They serve as central hubs for various tasks, including:
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Study Design and Implementation: Coordinating centers create rules and frameworks governing data collection, use, and dissemination. They also manage study design and implementation.
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Data Management: Coordinating centers handle data coordination, ensuring accurate and efficient data collection, storage, and analysis.
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Administrative Support: They assist with budget management, regulatory filings, site selection, investigator training, and form development.
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Biostatistical Leadership: Coordinating centers provide expertise in statistical analysis, contributing to the success of multicenter research programs.
There are two primary types of coordinating centers:
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Clinical Coordinating Centers (CCC): Responsible for clinical trial operations.
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Data Coordinating Centers (DCC): Focus on statistics and data management functions. These centers enhance study efficiency, accelerate results, and facilitate impactful research.
Additionally, the following represent other keyways the Coordinating and Data Management Centers are design to support multi-site research project funded by the National Institutes of Health.
Multi-Site Research Programs
Data Coordinating Center (DCC)
Data Management Center of Excellence (DMCOE)
The DMCOE focuses on collecting and assessing Findable, Accessible, Interoperable, and Reusable (FAIR) data management and sharing best practices. Its objectives include:
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Assessing the current landscape of NIH-supported data repositories.
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Gathering and distributing FAIR and data management resources to stakeholders both within and outside NIH.
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Facilitating adoption of best practices through training and learning support.
Data Management and Coordinating Centers (DMCCs)
These centers provide infrastructure and research support for various NIH-funded networks and clinical trials. For example:
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The DMCC supports a network of clinical sites, Diagnostic Centers of Excellence (DCoEs), and the Undiagnosed Diseases Program (UDP).
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The DMCCs collaborate to harmonize data and workflows across multiple Common Fund programs, enabling cross-dataset analysis.
Clinical Trials Management
In the context of multi-site investigator-initiated clinical trials, the Data Coordinating Center (DCC) provides overall project coordination, administration, data management, and biostatistical support. It works closely with the collaborating Clinical Coordinating Center (CCC).
These centers ensure efficient data management, coordination, and collaboration across NIH projects, ultimately advancing scientific research and improving health outcomes.
The University of Texas MD Anderson Cancer Center is honored to be designated as the Data Coordinating Center (DCC) by the National Institute of Diabetes and Digestive and Kidney Diseases for the Chronic Pancreatitis Clinical Research Consortium (CPCRC).
This honor aligns with our mission to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research, and prevention, as well as education for undergraduate and graduate students, trainees, professionals, employees, and the public.
The Department of Biostatistics at MD Anderson provides statistical collaboration, consultation, and quantitative research resources to clinical, laboratory, and prevention scientists, and engages in the planning, conduct, analysis, quality assurance, and interpretation of research studies. The faculty develop new statistical methodology to support cancer research: innovative clinical trial designs, Bayesian methods; longitudinal and survival data analysis; cancer screening and early detection; computer-intensive statistical methods for integrated high dimensional omics data analysis; functional, imaging, and biomarker data analysis; statistical modeling of observational processes; biological and medical informatics. The Department is supported by a Quantitative Research Computing (QRC) group, consisting of an Associate Director, 4 system and network administrators and a staff of 23 programmers who specialize in clinical trial software, data management, Bayesian numerical analysis, and bioinformatics and computational biology software engineering.
Data Coordinating Center (DCC)
Department and Expertise
The University of Texas MD Anderson Cancer Center is located within the Texas Medical Center, a 700-acre campus south of downtown Houston home to 46 not-for-profit institutions dedicated to providing the highest quality of medical care and conducting state-of-the-art research. MD Anderson Cancer Center provides world-class shared resources such as the Clinical and Translational Research Center, Research Animal Support Facility, Tissue Biospecimen and Pathology Resource, RNA sequencing facilities, and many others under the auspices of the Cancer Center Support Grant. MD Anderson is also home to the Institute for Personalized Cancer Therapy, dedicated to discovering biomarkers that predict treatment response and mechanisms of acquired resistance.
Data Coordinating Center (DCC)
Facilities and Resources
Data Coordinating Center (DCC)
Principal Investigators
Data Coordinating Center (DCC)
NIH Project Information
Project Abstract
Research in the treatment for diseases of the exocrine pancreas, including chronic pancreatitis (CP), pancreatogenic diabetes mellitus (DM), and pancreatic ductal adenocarcinoma (PDAC), has been hampered by disease heterogeneity, the lack of systematically collected clinical outcome measures in longitudinal studies linked with biospecimens, and the slow pace in biomarker and therapeutic development. Given the increasing incidence and prevalence of CP and its association to PDAC, its complications, high mortality rate, and associated healthcare cost, the NIH established in 2015 a consortium for the study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer as multidisciplinary teams to undertake a comprehensive clinical, epidemiological, and biological characterization of patients with CP (including recurrent acute pancreatitis) to develop treatments and biomarker tests, and gain insight into the pathophysiology of CP and its sequela: chronic pain, pancreatic exocrine and endocrine insufficiency, diabetes and pancreatic cancer association.
In the last nine years, the Coordination and Data Management Center (Center) of the Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer (Consortium) has provided critical administrative, regulatory, managerial, logistic, analytic, and financial functions for the consortium, enabling the successful launch of four multicenter studies (i.e., PROCEED, INSPPIRE 2, NOD, DETECT) that aim to understand the relationship between CP, DM, and PDAC, and to better define and characterize Type 3c diabetes.
In the next five years, the consortium will be renamed the Chronic Pancreatitis Clinical Research Consortium (CPCRC), and the Center will be renamed the Data Coordinating Center (DCC) to reflect the revised research focus on CP, both in children and adults, and to pursue and expand the objectives of the former consortium in these areas.
The DCC will further refine, optimize, and innovate its time-tested infrastructure, operation procedures, and organizational structure to provide strong and continued support for the CPCRC’s studies.
Specifically, we aim to:
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Provide operation and coordination support;
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Continue the accrual and follow-up for the two ongoing longitudinal cohort studies, PROCEED and INSPPIRE 2;
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Support the infrastructure for biomarker development and therapeutic trials, and manage the CPCRC biobank to process, safeguard, and distribute the study biospecimens for the conduct of studies approved by the CPCRC; and
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Design and support new studies selected by the CPCRC.
Public Health Relevance Statement
Project Narrative (Relevance to Public Health – 2 or 3 sentences): The proposed study is highly relevant to public health because chronic pancreatitis is associated with a significant disease burden, poor quality of life, and many co-morbidities, including an elevated risk of pancreatic cancer, the fourth largest killer among all cancers, despite a relatively low incidence rate. This proposed project generates fundamental knowledge on the natural history of chronic pancreatitis and supports the development of effective interventions, diagnostic biomarkers, and prognostic tools.
The National Cancer Institute (NCI) is the federal government's principal agency for cancer research and training. NCI is deeply committed to the core values of equity, diversity, and inclusion that allow all staff to reach their potential and fully contribute to the institute’s cancer mission.
NCI Professional Judgement Authority
The National Cancer Act of 1971 gives the NCI Director special authority to submit an annual professional judgment budget directly to the President for review and delivery to Congress. This budget reflects NCI cancer research priorities and identifies areas of potential investment in cancer research.
Stage I
The White House Office of Management & Budget (OMB) coordinates with federal agencies to formulate the President's Budget, which covers all federal agencies, including the National Cancer Institute (NCI) and National Institutes of Health (NIH), and reflects the President's priorities. The President submits the budget to Congress, which must pass appropriations legislation that funds federal agencies.
Stage III
The appropriations committees finalize their legislative proposals, and the House and Senate consider the proposed legislation. Once passed and reconciled into a unified bill, Congress sends the legislation to the President.
Stage IV
The President signs the appropriations bill into law, making funds available to executive agencies, including National Cance Institute and the National Institutes of Health.
Stage II
The congressional appropriations committees consider the President's Budget as they prepare appropriations legislation for the next fiscal year.
The National Cancer Institute receives its funding, or appropriation, from Congress as part of the overall federal budget process. So, how does the National Institutes of Health and the National Cancer Institute receive funding for research projects?
How the National Cancer Institute (NCI) Receives Its Funding
Watch Driving Discovery, a video by the National Cancer Institute demonstrating how they drive the cancer research enterprise by supporting and convening researchers, paying for facilities and systems, coordinating the nation's cancer plan, and more for our joint cancer-related initiatives.
National Cancer Institute: Driving Discovery
Types of
Cancer Research
Basic Research seeks to understand the fundamental aspects of nature. It provides the foundation for advances against cancer.
Basic Research
Clinical Research tests drugs, medical devices, or other interventions in human volunteers to improve aspects of patient care.
Clinical Research
Population-based research explores the cause of cancer, cancer trends, and factors that affect the delivery and outcomes of cancer care in specific populations.
Population-Based Research
Translational Research moves basic research findings into clinic and clinic research findings into everyday care. In turn, results from clinical and population-based studies can guide basic research.
Translational Research
