NCT03099850

Brief Summary

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:

  • Baylor College of Medicine
  • Cedars-Sinai Medical Center
  • University of Florida
  • Indiana University
  • Mayo Clinic
  • University of Minnesota
  • Ohio State University
  • Stanford University
  • University of Pittsburgh 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".

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,345

participants targeted

Target at P75+ for all trials

Timeline
50mo left

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Feb 2017Jun 2030

Study Start

First participant enrolled

February 28, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

13.3 years

First QC Date

March 15, 2017

Last Update Submit

October 10, 2025

Conditions

Pancreatitis

Keywords

Chronic PancreatitisData managementRegulatory complianceProtocol monitoring

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Observational cohort study of adult patients with suspected or definite CP

* Chronic Upper Abdominal Pain of Suspected Pancreatic Origin * Suspected Chronic Pancreatitis (Patients with Acute Pancreatitis, Recurrent Acute Pancreatitis, or Indeterminate CP without prior AP) * Definite Chronic Pancreatitis * Chronic Abdominal Pain- Undifferentiated Group

Other: Data Management and Monitoring

Interventions

Data Management and MonitoringOTHER

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. * 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

Observational cohort study of adult patients with suspected or definite CP

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants recruited from external sites.

You may qualify if:

  • \. Participants with chronic pancreatitis.

You may not qualify if:

  • ALL GROUPS EXCEPT GREEN GROUP I:
  • History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected
  • Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1 cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
  • Pancreatic metastasis from other malignancies.
  • History of solid organ transplant, HIV/AIDS.
  • 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.
  • 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).
  • Failure to agree for longitudinal follow-up.
  • 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.
  • Currently incarcerated.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77339, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 36191836DERIVED

  • 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.

    PMID: 36038644DERIVED

  • 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.

    PMID: 34571258DERIVED

Related Links

MeSH Terms

Conditions

PancreatitisPancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Li Liang, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Liang, PHD

CONTACT

713-563-4276lli15@mdanderson.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2017

First Posted

April 4, 2017

Study Start

February 28, 2017

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

October 14, 2025

Record last verified: 2025-10

Locations

US(1)