Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies, the PROCEED Study

Chronic Pancreatitis Clinical Trial

Official title: Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (The PROCEED Study)

Status Recruiting

Clinical Trial Summary

This study gathers information on patients at different stages of chronic pancreatitis to better understand the natural course and risk factors associated with pancreatitis. Chronic pancreatitis is a disease that occurs when the pancreas is inflamed (swollen and irritated) all of the time. It is important for doctors to diagnose chronic pancreatitis in the beginning stages of the disease. Over time, as chronic pancreatitis gets worse, the pancreas may stop working correctly. Since treatment options for advanced (end-stage) chronic pancreatitis are limited, patients with early-stage chronic pancreatitis or those at high risk of developing chronic pancreatitis are ideally suited for interventions to prevent the development of end-stage chronic pancreatitis and its associated complications. Information from this study may help researchers to develop lab tests for early diagnosis and prediction of disease progression, to understand disease mechanisms, and to discover genetic factors affecting susceptibility and progression.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To establish a model longitudinal research cohort of adult patients for the study of chronic pancreatitis (CP) and its complications.

II. To estimate the risk of progression from suspected to definite CP, and the risk of new-onset diabetes or exocrine insufficiency in definite CP, and study how the risks are influenced by patient characteristics and conditions.

III. To test the predictive capability of candidate biomarkers for diagnosis and prognosis of CP.

IV. To develop a framework for conducting biomarker, genetic, and mechanistic studies using clinical information and the biorepository developed as part of the longitudinal research cohort.

SECONDARY OBJECTIVES:

I. In patients with suspected and definite CP, to study:

Ia. The risk of pancreatic cancer. (Clinical) Ib. The natural history of pain and its predictors (demographic, environmental, clinical, and morphological). (Clinical) Ic. Quantitative changes in quality of life and disability and their predictors (demographic, environmental, clinical, and morphological). (Clinical) Id. Composite and quantitative measures of morphological progression of CP. (Clinical) Ie. Frequency of single or composite patient-centered outcomes over time and their relationship with demographic, environmental, clinical and, morphological factors. (Clinical) If. The risk and predictors of metabolic bone disease. (Clinical) Ig. Long-term survival. (Clinical) II. To identify and validate a panel of biomarkers that discriminate patients with suspected or definite CP from the normal population and controls with unexplained upper abdominal pain but no morphological evidence of pancreatic disease. (Biomarkers and Mechanism of Disease) III. To identify and validate biomarkers that predict future development of important clinical outcomes for patients with indeterminate presentations, including progression to definite CP, occurrence of disease complications, cumulative disability, and quality of life over time. (Biomarkers and Mechanism of Disease) IV. To develop biomarkers that can define specific aspects of CP pathophysiology (including inflammation, fibrosis, acinar loss, ischemia and neuropathy) and to correlate these with disease stage and mechanisms. (Biomarkers and Mechanism of Disease) V. To develop and validate biomarkers suitable as intermediate outcome measures in therapeutic trials. (Biomarkers and Mechanism of Disease)

OUTLINE: Participants are assigned to 1 of 4 groups.

GROUP I (NO PANCREATIC DISEASE): Participants undergo collection of blood, urine, saliva, and stool samples at baseline.

GROUP II (CHRONIC UPPER ABDOMINAL PAIN): Patients undergo collection of blood, urine, saliva, and stool samples, and intravenous (IV) contrast-enhanced magnetic resonance imaging (MRI) over 1.5-2 hours and computed tomography (CT) at baseline. Patients also undergo endoscopic ultrasound (EUS) or esophagogastroduodenoscopy (EGD) with collection of pancreatic fluid samples at baseline and year 2 (in a subset of patients). Patients may also undergo collection of blood and urine samples at year 2.

GROUP III (ACUTE PANCREATITIS, RECURRENT ACUTE PANCREATITIS, OR INDETERMINE CP): Patients undergo collection of saliva and stool samples at baseline, and collection of blood and urine at baseline and yearly for years 1-4. Patient also undergo contrast-enhanced MRI over 1.5-2 hours at baseline, and years 1 and 3, and IV contrast-enhanced CT at baseline, and years 2 and 4. Patients also undergo EUS or EGD with collection of pancreatic fluid samples at baseline and year 2 (in a subset of patients).

GROUP IV (DEFINITE CP): Patients undergo collection of saliva and stool samples at baseline, and collection of blood and urine at baseline and yearly for years 1-4. Patients also undergo EUS or EGD with collection of pancreatic fluid samples at baseline. Patients also undergo IV contrast-enhanced CT and MRI over 1.5-2 hours at baseline and years 1 and 3, and bone mineral density scan over 15 minutes at baseline and years 2 and 4.

Patients in Groups II to IV are followed up yearly for 20 years. ;

Related Conditions & MeSH terms

• Acute Pancreatitis
• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

• NCT number: NCT04753255
• Study type: Observational
• Source: M.D. Anderson Cancer Center
• Contact: Liang Li
• Phone: (713) 745-1146
• Email: lli15@mdanderson.org
• Status: Recruiting
• Start date: April 1, 2021
• Completion date: March 31, 2022