Diagnostic Strategies, Risk Assessment and Progression of Pancreatic Cysts
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients age 18 years and older
Referred for assessment of a pancreatic cyst.
Disqualifiers
Medically ill patients with American Society of Anesthesiologists class 4 or greater.
Inability to provide informed consent.
Pregnancy or lactation.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
15 yearsSponsors and contacts
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Johns Hopkins University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov