Early Detection of Pancreatic Cystic Neoplasms

Pancreatic Cysts Clinical Trial

Official title:

Early Detection of Pancreatic Cystic Neoplasms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02110498
• Other study ID #: NA_00084662
• Status: Recruiting
• Start date: March 2014
• Est. completion date: March 2034

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: Kathy Judge
• Phone: 4105027460
• Email: Romanka[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 2034
• Est. primary completion date: March 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic, Mucinous and/or Serous Neoplasm
• Intraductal Papillary Mucinous Neoplasm
• Neoplasms
• Neoplasms, Cystic, Mucinous, and Serous
• Pancreatic Cyst
• Pancreatic Cysts
• Pancreatic Mucinous-Cystic Neoplasm
• Pancreatic Neoplasms
• Solid Pseudopapillary Tumour of the Pancreas

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Lustgarten Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To determine the proportion of patients with malignancy in operable pancreatic cysts		3 years
Primary	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	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