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Early Detection of Pancreatic Cystic Neoplasms

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ClinicalTrials.gov Identifier: NCT02110498
Recruitment Status : Recruiting
First Posted : April 10, 2014
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This research is being done to learn more about pancreatic cysts. The tests that are currently available are imperfect at determining exactly what type of pancreatic cyst a person has, which cysts contain cancer, or what the risk is of developing cancer in the future. The aim of this study is to use a combination of clinical, imaging, cyst fluid analysis, and molecular markers to try to help develop better tools to answer these questions.

Condition or disease
Pancreatic Cysts Intraductal Papillary Mucinous Neoplasm Pancreatic Mucinous-Cystic Neoplasm Cystic, Mucinous and/or Serous Neoplasm Solid Pseudopapillary Tumour of the Pancreas

Detailed Description:

Incidental pancreatic cysts are increasingly recognized due to the widespread use of cross-sectional imaging techniques such as CT and MRI. A number of lesions in the pancreas can form cysts, including serous cystadenomas (SCA), mucinous cystic neoplasms (MCNs), intraductal papillary mucinous neoplasms (IPMNs), solid-pseudopapillary neoplasms (SPNs), and pseudocysts. SCAs and pseudocysts are considered benign; whereas SPNs are considered malignant and require surgical resection. IPMNs and MCNs are considered neoplasms with malignant potential, although the exact risk of malignant progression of these cysts is unknown. Currently, MCN are all surgically resected, whereas IPMN are resected if they have features suspicious for malignancy.

However, current diagnostic tests cannot always reliably distinguish harmless from potentially harmful cysts. Recent studies conducted at Johns Hopkins have shown that each cyst type has unique genetic features that could be used as diagnostic biomarkers. In this study, clinical, imaging data and cyst fluid analysis of individuals with pancreatic cysts will be collected. In patients who undergo an endoscopic ultrasound (EUS) procedure, if a fine needle aspiration (EUS-FNA) is performed, and there is extra cyst fluid left after standard clinical tests have been sent, the extra cyst fluid will be submitted for molecular marker analysis. If an individual undergoes surgery to remove the cyst, cyst fluid will be collected after the cyst has been removed. In addition, a small amount of blood will be collected at the time of the EUS or surgical procedure.

AIMS: The general 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.


Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Pancreatic Cystic Neoplasms
Study Start Date : March 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019



Primary Outcome Measures :
  1. To develop and prospectively validate a panel of molecular markers to differentiate benign pancreatic cysts from those with malignant potential using surgical pathology as the gold standard [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To determine the sensitivity, specificity, and overall accuracy of imaging (CT, MRI and EUS) in patients with pancreatic cysts [ Time Frame: 3 years ]
    Sensitivity and specificity of imaging results in identifying malignant and mucinous cysts will be calculated using the pathology result as the reference gold standard. The overall accuracy of the imaging results, defined as percent agreement with pathology, will also be calculated. Estimates will be reported with exact binomial 95% confidence intervals.


Other Outcome Measures:
  1. To determine the proportion of patients with malignancy in operable pancreatic cysts [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Pancreatic cyst fluid, blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any individual with a pancreatic cyst seen at the Johns Hopkins Hospital or other participating Institutions.
Criteria

Inclusion Criteria:

  • Adult patients age 18 years and older with pancreatic cyst.

Exclusion Criteria:

  • Individuals with ASA class 4 or greater.
  • Inability to provide informed consent.
  • Pregnancy or lactation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110498


Contacts
Contact: Kathy Judge 4105027460 Romanka@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Anne Marie O'Broin-Lennon, MD, PhD Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02110498     History of Changes
Other Study ID Numbers: NA_00084662
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by Johns Hopkins University:
Pancreatic cyst
IPMN
SCA
SPN
MCN
pancreatic cystic neoplasm

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