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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01DK108328-01 | U.S. NIH Grant/Contract | View source | |
| 2020-1058 | Other Identifier | MD Anderson Cancer Center | |
| NCI-2021-00441 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Institutes of Health (NIH) | NIH |
| University of Minnesota | OTHER |
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The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCCEED) Study, which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). No patient enrollment will occur at MDACC. All patient recruitment will occur at external sites that are a part of the CPDPC. The data management systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support Center (CRSC).
PROCEED is the first study in the USA that is carefully following participants to better understand factors that may be responsible for causing pancreatitis and how it progresses. The study is being conducted at the following 9 major clinical centers across the US:
The study is enrolling participants who are at different stages of chronic pancreatitis, including those with no known pancreas disease (controls), and those with abdominal pain, one or more attacks of pancreatitis, or chronic pancreatitis. After enrollment, participants with abdominal pain and pancreatitis are asked to follow-up every year to learn about their symptoms and any changes in the disease. PROCEED investigators plan to use the detailed information they collect to better understand the disease and identify new treatments.
"More details and updated information about this study can be found at the study's public website: https://www.cpdpc-research-consortium.org/research- study-cpdpc-16-02-proceed".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational cohort study of adult patients with suspected or definite CP |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data Management and Monitoring | Other | The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer Center responsible for monitoring protocol and regulatory compliance for consortium. CDMC responsible for maintaining and tracking IRB approval and regulatory documents from each site throughout the life of the study.
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and adverse events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year. |
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Inclusion Criteria:
1. Participants with chronic pancreatitis.
Exclusion Criteria:
ALL GROUPS EXCEPT GREEN GROUP I:
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Participants recruited from external sites.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Liang, PHD | Contact | 713-563-4276 | lli15@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Li Liang, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77339 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36191836 | Derived | Yadav D, Askew RL, Palermo T, Li L, Andersen DK, Chen M, Fisher WE, Fogel EL, Forsmark CE, Hart PA, Othman MO, Pandol SJ, Park WG, Topazian MD, Van Den Eeden SK, Vege SS, Yang Y, Serrano J, Conwell DL; Consortium for the Study of Chronic Pancreatitis, Diabetes; Pancreatic Cancer (CPDPC). Association of Chronic Pancreatitis Pain Features With Physical, Mental, and Social Health. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1781-1791.e4. doi: 10.1016/j.cgh.2022.09.026. Epub 2022 Oct 1. | |
| 36038644 |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| Ohio State University |
| OTHER |
| Baylor College of Medicine | OTHER |
| Indiana University | OTHER |
| University of Florida | OTHER |
| Cedars-Sinai Medical Center | OTHER |
| Stanford University | OTHER |
| Mayo Clinic | OTHER |
| University of Pittsburgh Medical Center | OTHER |
| Kaiser Permanente | OTHER |
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| Tirkes T, Yadav D, Conwell DL, Territo PR, Zhao X, Persohn SA, Dasyam AK, Shah ZK, Venkatesh SK, Takahashi N, Wachsman A, Li L, Li Y, Pandol SJ, Park WG, Vege SS, Hart PA, Topazian M, Andersen DK, Fogel EL; Consortium for the Study of Chronic Pancreatitis, Diabetes, Pancreatic Cancer (CPDPC). Quantitative MRI of chronic pancreatitis: results from a multi-institutional prospective study, magnetic resonance imaging as a non-invasive method for assessment of pancreatic fibrosis (MINIMAP). Abdom Radiol (NY). 2022 Nov;47(11):3792-3805. doi: 10.1007/s00261-022-03654-7. Epub 2022 Aug 29. |
| 34571258 | Derived | Hart PA, Yadav D, Li L, Appana S, Fisher W, Fogel E, Forsmark CE, Park WG, Pandol S, Topazian MD, Van Den Eden SK, Vege SS, Bradley D, Serrano J, Conwell DL; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). High Prevalence of Osteopathy in Chronic Pancreatitis: A Cross-sectional Analysis From the PROCEED Study. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2005-2013. doi: 10.1016/j.cgh.2021.09.026. Epub 2021 Sep 24. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |