Early Detection of Pancreatic Cystic Neoplasms

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT02110498
Study type	Observational
Source	Johns Hopkins University
Contact	Kathy Judge
Phone	4105027460
Email	Romanka@jhmi.edu
Status	Recruiting
Phase
Start date	March 2014
Completion date	March 2034

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01624363` - Prevalence of Pancreatic Cysts During Routine Endoscopic Ultra Sound	N/A
Completed	`NCT01447238` - Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy-A Pilot Study
Completed	`NCT01202136` - The Clinical,Radiologic,Pathologic and Molecular Marker Characteristics of Pancreatic Cysts Study
Completed	`NCT01698710` - Endoscopic Abraxane Injection Into Pancreatic Cysts	N/A
Completed	`NCT00828048` - International Registry for Intraductal Papillary Mucinous Neoplasma
Terminated	`NCT02494388` - Needle-based Confocal Laser Endomicroscopy on Pancreatic Cystic Lesions	N/A
Terminated	`NCT01769534` - Registry and Fluid Banking of Pancreatic Cystic Lesions	N/A
Recruiting	`NCT04400357` - Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors	N/A
Completed	`NCT01236300` - In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors	N/A
Completed	`NCT01929460` - A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration	N/A
Completed	`NCT01883336` - Long Term Follow up of Small Non-inflammatory Pancreatic Cysts
Completed	`NCT01035008` - Confocal Endomicroscopy of Pancreatic InVivo	N/A
Completed	`NCT01392027` - Biospecimens for Identification of Diseases of the Pancreas.	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.