Diagnostic Strategies, Risk Assessment and Progression of Pancreatic Cysts

Pancreas Cancer Clinical Trial

Official title:

Diagnostic Strategies, Risk Assessment and Progression of Pancreatic Cysts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04473794
• Other study ID #: IRB00249790
• Secondary ID: 5P50CA062924
• Status: Recruiting
• Start date: July 20, 2022
• Est. completion date: August 1, 2036

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Elham Afghani, MD MPH
• Phone: 410-614-6708
• Email: eafghan1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: August 1, 2036
• Est. primary completion date: November 1, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Cyst
• Pancreatic Neoplasms

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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