Diagnostic Strategies, Risk Assessment and Progression of Pancreatic Cysts

The aims of this study are to determine the natural history of pancreatic cysts and to propose and prospectively validate a diagnostic approach and model for prediction of mucinous versus non-mucinous, and malignant versus non-malignant, pancreatic cysts using a combination of clinical, radiologic, and biomarker characteristics.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Neoplasms; Pancreas Cancer

Detailed Description

Pancreatic cysts are increasingly recognized as incidental lesions due to the widespread use of cross-sectional imaging techniques such as CT and MRI. Twenty percent of all pancreatic cysts are non-inflammatory cystic neoplasms, many of which are mucinous, and therefore have a significant potential for malignant transformation. The primary challenge facing clinicians is the inability of current standard diagnostic tests, including imaging and standard laboratory data, to accurately and reliably discriminate neoplastic from non-neoplastic, and benign from malignant cysts, particularly in patients without symptoms. Therefore, some patients with benign cysts undergo unnecessary costly surveillance and possible avoidable surgical resections, which is associated with high cost, significant morbidity and mortality, while some may not be as aggressively followed. The International Association of Pancreatology (IAP) has published guidelines on the management of the two main types of mucinous cystic lesions: intraductal papillary mucinous neoplasms (IPMNs) and mucinous cystic neoplasms (MCNs). (1) Although these guidelines emphasize the frequency of surveillance and outline the indications for resection, these guidelines have not yet been validated, and these guidelines presume the diagnosis of a mucinous neoplastic cyst has been confirmed prior to surgery. It is unlikely that guidelines that only use clinical and imaging will be able to accurately differentiate benign cysts from those that are pre-malignant or currently harbor malignancy. Hence, there is a critical need for a diagnostic model that more accurately diagnoses neoplastic mucinous and malignant pancreatic cysts as this will improve the management of many patients with pancreatic cysts.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Elham Afghani, MD MPH; Phone Number: 410-614-6708; Email: eafghan1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • The Johns Hopkins Hospital
      • Contact: Elham Afghani, MD MPH; Phone Number: 410-614-6708; Email: eafghan1@jhmi.edu
      • Contact: Vaishnavi S Sawant, MBBS MPH; Phone Number: 443-603-5875; Email: vsawant1@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

As part of standard care, patients will have a consultation (clinic) visit with a gastroenterologist or surgeon. Patients will be followed per the standard of care at each institution. There are no required study visits. There will be no blinding performed in this study. All patients will receive standard (routine) medical care. No placebo or non-treatment group will be enrolled. There is no treatment failure. Patients will only be removed from the study if patients request this. When the study ends, or if a patient ends his or her participation prematurely, all patients will continue to receive medical and/or surgical care from patients' respective physicians based on currently available published data and clinical experience.

Description

Inclusion Criteria:

• Adult patients age 18 years and older
• Referred for assessment of a pancreatic cyst.

Exclusion Criteria:

• Medically ill patients with American Society of Anesthesiologists class 4 or greater.
• Inability to provide informed consent.
• Pregnancy or lactation.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical utility of Compcyst in pancreatic cysts as assessed by patient chart review	Compcyst is part of the new standard of care diagnosis of precancerous and benign cystic lesions. Patient charts will be reviewed for clinical, radiological, surgical and pathologic information (all combined into a composite) that will be used to determine if Compcyst as part of the new standard of care is better than the diagnostic measure in the old standard of care in detecting precancerous and benign cystic lesions. Patient records over a 15-year period will be reviewed.	15 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Elham Afghani, MD MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): August 1, 2036

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Cysts; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Pancreatic Cyst
• Other Study ID Numbers: IRB00249790; 5P50CA062924 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No