Early Detection of Pancreatic Cystic Neoplasms

This research is being done to learn more about pancreatic cysts. The tests that are currently available are imperfect at determining exactly what type of pancreatic cyst a person has, which cysts contain cancer, or what the risk is of developing cancer in the future. The aim of this study is to use a combination of clinical, imaging, cyst fluid analysis, and molecular markers to try to help develop better tools to answer these questions.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Mucinous-Cystic Neoplasm; Pancreatic Cysts; Intraductal Papillary Mucinous Neoplasm; Solid Pseudopapillary Tumour of the Pancreas; Cystic, Mucinous and/or Serous Neoplasm

Detailed Description

Incidental pancreatic cysts are increasingly recognized due to the widespread use of cross-sectional imaging techniques such as CT and MRI. A number of lesions in the pancreas can form cysts, including serous cystadenomas (SCA), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs), solid-pseudopapillary neoplasms (SPNs), and pseudocysts. SCAs and pseudocysts are considered benign; whereas SPNs are considered malignant and require surgical resection. IPMNs and MCNs are considered neoplasms with malignant potential, although the exact risk of malignant progression of these cysts is unknown. Currently, MCN are all surgically resected, whereas IPMN are resected if they have features suspicious for malignancy.

However, current diagnostic tests cannot always reliably distinguish harmless from potentially harmful cysts. Recent studies conducted at Johns Hopkins have shown that each cyst type has unique genetic features that could be used as diagnostic biomarkers. In this study, clinical, imaging data and cyst fluid analysis of individuals with pancreatic cysts will be collected. In patients who undergo an endoscopic ultrasound (EUS) procedure, if a fine needle aspiration (EUS-FNA) is performed, and there is extra cyst fluid left after standard clinical tests have been sent, the extra cyst fluid will be submitted for molecular marker analysis. If an individual undergoes surgery to remove the cyst, cyst fluid will be collected after the cyst has been removed. In addition, a small amount of blood will be collected at the time of the EUS or surgical procedure.

AIMS: The general aim is 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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Kathy Judge; Phone Number: 4105027460; Email: Romanka@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Recruiting
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Any individual with a pancreatic cyst seen at the Johns Hopkins Hospital or other participating Institutions.

Description

Inclusion Criteria:

• Adult patients age 18 years and older with pancreatic cyst.

Exclusion Criteria:

• Individuals with ASA 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	Time Frame
To develop and prospectively validate a panel of molecular markers to differentiate benign pancreatic cysts from those with malignant potential using surgical pathology as the gold standard	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the sensitivity, specificity, and overall accuracy of imaging (CT, MRI and EUS) in patients with pancreatic cysts	Sensitivity and specificity of imaging results in identifying malignant and mucinous cysts will be calculated using the pathology result as the reference gold standard. The overall accuracy of the imaging results, defined as percent agreement with pathology, will also be calculated. Estimates will be reported with exact binomial 95% confidence intervals.	3 years

Other Outcome Measures

Outcome Measure	Time Frame
To determine the proportion of patients with malignancy in operable pancreatic cysts	3 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Lustgarten Foundation
• Investigators: Principal Investigator: Anne Marie O'Broin-Lennon, MD, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Estimated): March 1, 2034
• Study Completion (Estimated): March 1, 2034

Study Registration Dates

• First Submitted: March 30, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimated): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: SCA; pancreatic cystic neoplasm; IPMN; Pancreatic cyst; SPN; MCN
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Cysts; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms; Pancreatic Neoplasms; Pancreatic Cyst; Neoplasms, Cystic, Mucinous, and Serous
• Other Study ID Numbers: NA_00084662