Clinical trial NCT02110498: Early Detection of Pancreatic Cystic Neoplasms
Official title: Early Detection of Pancreatic Cystic Neoplasms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cysts
Intraductal Papillary Mucinous Neoplasm
Pancreatic Mucinous-Cystic Neoplasm
Cystic, Mucinous and/or Serous Neoplasm
Solid Pseudopapillary Tumour of the Pancreas
Keywords: Pancreatic cyst
IPMN
SCA
SPN
MCN
pancreatic cystic neoplasm
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Lustgarten Foundation
First posted: 2014-04-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual with a pancreatic cyst seen at the Johns Hopkins Hospital or other participating Institutions.

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.

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.

Primary outcomes:
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: To determine the sensitivity, specificity, and overall accuracy of imaging (CT, MRI and EUS) in patients with pancreatic cysts
timeFrame: 3 years
Other outcomes:
measure: To determine the proportion of patients with malignancy in operable pancreatic cysts
timeFrame: 3 years
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Anne Marie O'Broin-Lennon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: