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
|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|
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|
|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|
- 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 ]
- 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.
- To determine the proportion of patients with malignancy in operable pancreatic cysts [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
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
|Contact: Kathy Judge||4105027460||Romanka@jhmi.edu|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Anne Marie O'Broin-Lennon, MD, PhD||Johns Hopkins University|