The Clinical,Radiologic,Pathologic and Molecular Marker Characteristics of Pancreatic Cysts Study

NCT01202136 | Completed

• 1 other identifier: NA_00026447
• Study Type: observational
• Target: 477
• Locations: 1 country
• Sites: 2

Brief Summary

The 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.

Conditions

Pancreatic Cysts; Pancreatic Cancer

Keywords

pancreatic cyst; IPMN; PAN INs; Pancreatic cancer; pancreatic neoplasia

Outcome Measures

Primary Outcomes (1)

• Prevalence and incidence of malignant pancreatic cysts

  1)to determine the prevalence and incidence of malignancy in pancreatic cysts according to cyst size and concerning features

  3-6 years

Secondary Outcomes (6)

• Biomarkers to predict type of pancreatic cyst

  3-6 years

• Biomarker panel in pancreatic juice as indicator to type of pancreatic cyst

  3-6 years

• Compare CT with EUS and MRI for diagnosing pancreatic cysts.

  3-6 year

• Difference EUS/CT or MRCP in diagnosis of malignant pancreatic cysts

  3-6 years

• Associated factors for with multivariate model for malignant pancreatic cyst

  3-6 years

Study Arms (1)

Pancreatic cysts

patients referred to Johns Hopkins Hospital for evaluation and or treatment for 1 or more pancreatic cysts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to Johns Hopkins for evaluation of pancreatic cysts

You may qualify if:

• Adult patients age 18 years and older
• Referred for assessment of one or more pancreatic cyst.

You may not qualify if:

• Medically ill patients with ASA class 4 or greater.
• History of chronic kidney disease with a serum creatinine \> 2.0 mg/dl or estimated glomerulofiltration rate (eGFR) \< 30 ml/min, dialysis patients, acute renal failure, cirrhosis of the liver, chronic hepatitis, prior nephrectomy or kidney or liver transplantation.
• History of moderate (generalized hives) or severe (facial swelling, airway reaction) reaction to intravenous radiographic contrast material.
• History of obstruction in the upper GI tract such as esophageal or pyloric stricture, which would not allow passage of an endoscope.
• Bleeding diathesis (clotting problems) or a history of thrombocytopenia (low platelet count \<50,000).
• Inability to provide informed consent.
• Pregnancy or lactation.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Lustgarten Foundation: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, pancreatic cyst fluid

MeSH Terms

Conditions

Pancreatic Cyst; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Anne Marie O'Broin-Lennon, MD

  John Hopkins University, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 15, 2010
• Study Start: October 1, 2012
• Primary Completion: January 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (2)