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NCT Number: NCT04473794

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Clinical utility of Compcyst in pancreatic cysts as assessed by patient chart review

    Time frame: 15 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elham Afghani, MD MPH

CONTACT

[email protected]

410-614-6708

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2022
Primary completion
2035
Study completion
2036
First posted
Jul 16, 2020
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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