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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Lustgarten Foundation
Information provided by (Responsible Party):
Dr. Anne Marie O'Broin-Lennon, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01202136
First received: September 9, 2010
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition
Pancreatic Cysts
Pancreatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Clinical,Radiologic, Pathologic and Molecular Marker Characteristics of Premalignant and Malignant Pancreatic Cysts Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Prevalence and incidence of malignant pancreatic cysts [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
    1)to determine the prevalence and incidence of malignancy in pancreatic cysts according to cyst size and concerning features


Secondary Outcome Measures:
  • Biomarkers to predict type of pancreatic cyst [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
    To collect tissue samples (cyst fluid and blood) for research on molecular markers in pancreatic cysts

  • Biomarker panel in pancreatic juice as indicator to type of pancreatic cyst [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
    To develop a panel of candidate biomarkers in pancreatic juice and serum as indicators of prevalent and incident malignancy in patients with surgically-proven neoplastic pancreatic cysts compared to non-neoplastic cysts (pseudocysts, lymphoepithelial cysts, congenital cysts)

  • Compare CT with EUS and MRI for diagnosing pancreatic cysts. [ Time Frame: 3-6 year ] [ Designated as safety issue: No ]
    to determine the sensitivity, specificity, and overall accuracy of pancreatic protocol CT, EUS, and/or MRCP in patients with pancreatic cysts, using surgical pathology as the reference standard

  • Difference EUS/CT or MRCP in diagnosis of malignant pancreatic cysts [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
    to calculate difference in diagnostic accuracy and clinical impact (change in preoperative diagnosis and treatment plan) of additional diagnostic tests (EUS and/or MRCP) over pancreatic protocol CT for the diagnosis of neoplastic/malignant pancreatic cysts.

  • Associated factors for with multivariate model for malignant pancreatic cyst [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
    to determine the factors associated with prevalent and incident malignancy in pancreatic cyst using a multivariate model including clinical, radiologic, and molecular markers

  • Model for prediction of malignant pancreatic cysts [ Time Frame: 3-6 years ] [ Designated as safety issue: No ]
    to determine the best model for prediction of malignancy in pancreatic cysts using multiple logistic regression and discriminant function analysis, including clinical, radiologic, and molecular markers


Biospecimen Retention:   Samples With DNA

Blood, pancreatic cyst fluid


Estimated Enrollment: 450
Study Start Date: October 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pancreatic cysts
patients referred to Johns Hopkins Hospital for evaluation and or treatment for 1 or more pancreatic cysts

Detailed Description:

This combined cross-sectional and prospective single center clinical and translational study involves a collaborative multidisciplinary team composed of gastroenterologists, surgeons, radiologists, and basic scientists. Eligible patients with solitary or multiple pancreatic cysts referred for diagnostic evaluation and/or surgical treatment will undergo initial radiographic imaging with high-resolution CT, MRI/MRCP, and EUS/FNA as part of standard medical care at Johns Hopkins Hospital. This is a three-phase study.

In Phase I, eligible patients with pancreatic cysts will undergo initial radiographic imaging (high-resolution CT, MRI/MRCP, endoscopic ultrasonography (EUS) with fine needle aspiration (FNA)) as part of standard care at the Johns Hopkins Hospital. Patients will be categorized according to the presence of symptoms referable to the cyst or imaging features concerning for malignancy based on the initial radiographic assessment. Symptomatic patients, or those with concerning features, will be referred for surgical resection. The pathologic features and final diagnosis of resected pancreatic cysts will be compared with preoperative clinical, radiologic, and cyst fluid test results.

Asymptomatic patients with low-risk features at baseline radiographic and endoscopic imaging will enter Phase II. Patients will be followed on a prospective periodic surveillance schedule according the consensus clinical guidelines with either CT or MRI to monitor for new or metachronous cystic neoplasms. Those who develop symptoms or concerning features will have a repeat EUS/FNA as well as imaging with the opposite axial imaging modality, and will be referred for surgery if a suspicious lesion is detected.

Patients who have surgery either during Phase I or Phase II, will enter post-surgical surveillance (Phase III). Patients will be followed using a prospective periodic surveillance schedule according the consensus clinical guidelines with either CT or MRI to monitor for new or metachronous cystic neoplasms. Those who undergo surgery after surveillance in Phase II will continue with the imaging modality they were originally evaluated with prior to surgery.. Patients who develop symptoms or high-risk features on imaging will have a repeat EUS/FNA as well as imaging with the opposite axial imaging modality and will be referred for surgery if a suspicious lesion is detected. Samples will be collected prospectively for biomarker analysis. Cyst fluid, pancreatic juice and blood will be collected during EUS and blood will be collected yearly during the outpatient clinic visit. Patients will be followed for three years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to Johns Hopkins for evaluation of pancreatic cysts

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Medically ill patients with ASA class 4 or greater.
  2. 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.
  3. History of moderate (generalized hives) or severe (facial swelling, airway reaction) reaction to intravenous radiographic contrast material.
  4. History of obstruction in the upper GI tract such as esophageal or pyloric stricture, which would not allow passage of an endoscope.
  5. Bleeding diathesis (clotting problems) or a history of thrombocytopenia (low platelet count <50,000).
  6. Inability to provide informed consent.
  7. Pregnancy or lactation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202136

Locations
United States, Maryland
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
The Lustgarten Foundation
Investigators
Principal Investigator: Anne Marie O'Broin-Lennon, MD John Hopkins University, School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Anne Marie O'Broin-Lennon, Assistant Professor of Gastroenterology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01202136     History of Changes
Other Study ID Numbers: NA_00026447
Study First Received: September 9, 2010
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
pancreatic cyst
IPMN
PAN INs
Pancreatic cancer
pancreatic neoplasia

Additional relevant MeSH terms:
Pancreatic Neoplasms
Cysts
Pancreatic Cyst
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 22, 2014