Diagnostic Strategies, Risk Assessment and Progression of Pancreatic Cysts

NCT04473794 | Recruiting

• 1 other identifier: IRB00249790
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Neoplasms; Pancreas Cancer

Outcome Measures

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.

  15 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Adult patients age 18 years and older
• Referred for assessment of a pancreatic cyst.

You may not qualify if:

• Medically ill patients with American Society of Anesthesiologists class 4 or greater.
• Inability to provide informed consent.
• Pregnancy or lactation.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood Surgical Tissue Pancreatic cyst fluid

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Elham Afghani, MD MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elham Afghani, MD MPH

CONTACT

410-614-6708; eafghan1@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 16, 2020
• Study Start: July 20, 2022
• Primary Completion (Estimated): November 1, 2035
• Study Completion (Estimated): August 1, 2036
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)