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

Chronic Pancreatitis Study

E
Evan Fogel, MD

Primary Investigator

Enrolling By Invitation
18 years - 75 years
All
Phase N/A
1 Location

Brief description of study

This study will provide the most accurate and reliable estimates to date on disease progression and clinical events in evolving chronic pancreatitis. We also hope to develop from the results of this study some lab tests that will help us with early diagnosis of chronic pancreatitis and also to discover any genetic factors that may affect your chances of developing chronic pancreatitis. The results of this study may also provide information that will open opportunities for new drug discovery.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - 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. Potential participant controls may be recruited though various tools, as well as approaching patients who come in for preventative services (screening colonoscopy, breast cancer screening, or influenza vaccination), and those being recruited as volunteers to other University studies. Participants in other study groups will be recruited through GI or Pancreas clinics or hospitalized patients.

Detailed description of study

This is an observational cohort study of adult patients with suspected or definite CP who will be prospectively ascertained and undergo yearly follow-up during clinical care. The study cohort will consist of three groups of participants who will be followed for the duration of this grant period and 20+ years: Definite CP, Suspected CP, and Controls. 

Subjects of varying health status but without symptoms or diagnosis of pancreatic disease and patients with unexplained upper abdominal pain but no evidence of pancreatic disease will be ascertained as controls, who will provide clinical information and biological samples at baseline. Subsets of participants will undergo radiologic and/or diagnostic endoscopic procedures for clinical or research purposes. Study participants will complete questionnaires at baseline and during yearly follow-up. In the event a participant does not complete all or part of the patient or coordinator questionnaire, the study coordinator will complete questions via medical record review (e.g., demographics and family history) or via a telephone interview.

  • Biospecimen collection: blood, urine, saliva, stool. Biospecimens will be collected and processed in accordance with the CPDPC specimen collection procedures.
  • EUS or EGD with pancreatic fluid collection
  • imaging studies performed at baseline and at follow-up; IV contrast-enhanced MRI and MRCP with secretin; IV contrast-enhanced CT Scan abdomen

Patients with unexplained upper abdominal pain will also undergo yearly follow-up during clinical care and a subset of them will provide biological samples. 

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.

As part of the study, we will collect blood, saliva, urine, stool, pancreas fluid (if applicable), and tissue (investigational purposes). If a subject goes through pancreatic surgery during the study period, we will attempt to collect pancreas tissue at the time of surgery.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pancreatitis, Pancreatic Diease, Healthy
  • Age: 18 years - 75 years
  • Gender: All

Inclusion Criteria (ALL GROUPS):
1)    All participants must sign an informed consent indicating that they are aware of the investigational nature of this study and willing to undergo study interventions, and authorizing the use of their protected health information for research purposes. 
2)    Meet one set of group-specific inclusion criteria for Chronic Pancreatitis, Suspected Chronic Pancreatitis, and Healthy Controls (no history of pancreatic disease).
3)    All participants must be ≥18 years old and ≤75 years at the time of enrollment. 

Inclusion Criteria:

1. Participants with chronic pancreatitis.

Exclusion Criteria:

ALL GROUPS EXCEPT GREEN GROUP I:

  1. History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected
  2. Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (>1 cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
  3. Pancreatic metastasis from other malignancies.
  4. History of solid organ transplant, HIV/AIDS.
  5. Known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible inclusion criteria).
  6. Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up.
  7. Patients with known abnormal creatinine (GFR < 30) or renal failure (applies to patients with chronic upper abdominal pain of suspected pancreatic origin and suspected CP (Yellow) subgroups).
  8. Failure to agree for longitudinal follow-up.
  9. Known Pregnancy. All participants of childbearing potential, except if post-menopausal [i.e. no menses for ≥2 years] or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum B-HCG pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test.
  10. Currently incarcerated.
  11. Inability to get MRI/MRCP in patients with chronic abdominal pain of suspected pancreatic origin (Green II) or Suspected CP (Yellow groups) at baseline (e.g. metal object in the body which precludes performance of MRI).

**ADDITIONAL CRITERIA APPLY, DEPENDING ON THE COHORT THE PARTICIPANT QUALIFIES FOR

 

This study investigates chronic pancreatitis, a condition where the pancreas becomes inflamed over a long period, causing damage. The purpose of this study is to understand how the disease progresses and to identify factors that may contribute to its development, including genetic factors. Participants include those with chronic pancreatitis, those suspected of having it, and healthy controls without pancreatic disease.

Study procedures involve collecting biological samples such as blood, urine, saliva, and stool. Some participants may undergo imaging studies like MRI or CT scans, or endoscopic procedures to collect pancreatic fluid. Participants will also complete questionnaires and may have follow-ups every year to monitor their health and any changes in their condition.

  • Who can participate: Adults aged 18 to 75 can participate. Participants must consent and meet criteria for chronic pancreatitis, suspected chronic pancreatitis, or be healthy controls.
  • Study details: Participants will provide biological samples and may undergo imaging or endoscopic procedures. They will complete questionnaires annually. A placebo is not involved in this observational study.
  • Study timelines: The study will last 20+ years.
Updated on 11 Dec 2025. Study ID: GI-NIH-FOGEL-PROCEED, 1701080233, 10835
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only