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Early Detection of Pancreatic Cystic Neoplasms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02110498
Recruitment Status : Recruiting
First Posted : April 10, 2014
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date March 30, 2014
First Posted Date April 10, 2014
Last Update Posted Date April 11, 2019
Study Start Date March 2014
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2014)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 8, 2014)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 8, 2014)
To determine the proportion of patients with malignancy in operable pancreatic cysts [ Time Frame: 3 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Early Detection of Pancreatic Cystic Neoplasms
Official Title Early Detection of Pancreatic Cystic Neoplasms
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Pancreatic cyst fluid, blood
Sampling Method Non-Probability Sample
Study Population Any individual with a pancreatic cyst seen at the Johns Hopkins Hospital or other participating Institutions.
Condition
  • Pancreatic Cysts
  • Intraductal Papillary Mucinous Neoplasm
  • Pancreatic Mucinous-Cystic Neoplasm
  • Cystic, Mucinous and/or Serous Neoplasm
  • Solid Pseudopapillary Tumour of the Pancreas
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 8, 2014)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kathy Judge 4105027460 Romanka@jhmi.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02110498
Other Study ID Numbers NA_00084662
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators Not Provided
Investigators
Principal Investigator: Anne Marie O'Broin-Lennon, MD, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date April 2019