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OpenTrials
Completed

NCT Number: NCT01565460

Bile and Bile Duct/Pancreatic Duct Brushings Database for Patients With Pancreato-biliary Stricture

The purpose of this study is to create a long-term storage of bile and brushings of pancreato-biliary duct in patients diagnosed with pancreato-biliary stricture for future research.

Recently, a lot of research has been done to test for certain markers in the bile and brushings to detect cancer in a stricture. The samples will be used to measure biomarkers (proteins) in biliary diseases.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

Recently, a lot of research has been done to test for certain markers like fluorescence in situ hybridization (FISH), digital image analysis (DIA), and quantifiable morphometric results in biliary stricture brushings. Recently, polysomy FISH has been studied as a promising marker in predicting cancer in a pancreato-biliary stricture. Many genetic, epigenetic, and protein alterations arise during pancreaticobiliary tumor process. The types of markers that have been commonly evaluated as diagnostic assays are mutations, chromosomal gains and losses, and DNA methylation alterations. However there are only a few studies in this area. Testing for these markers can help determine whether the narrowing or stricture in your bile duct is cancer or not.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient diagnosed with pancreato-biliary stricture.
  • Age >18 years
  • Ability to provide an informed consent

Exclusion criteria

  • Patients with altered mental status, who will not be able to provide an informed consent
  • Pregnant women

Treatment and study plan

Sample collection

Other

Sample Collection: bile and pancreatic duct brushings and fluid samples will be obtained from the pancreatic stricture during endoscopic retrograde cholangiopancreatic procedure.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 28, 2012
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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