Clinical Trial: The Role of ctDNA and PBMC in Treatment of Biliary Tract Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: The Role of ctDNA and PBMC as Biomarkers in Diagnostic, Efficacy Monitoring and Prognostic Evaluation of Biliary Tract Cancer

Brief Summary: Our study aims to evaluate the role of ct-DNA and PBMC as biomarkers in the treatment of biliary tract cancer.

Detailed Summary:

Biliary cancer ranked fifth in all gastrointestinal malignant cancer. Epidemiological surveys showed a significant increasing trend in recent years. How can make an early diagnosis of bile duct cancer as well as prognostic evaluation and efficacy monitoring, has become the hotspot. "liquid biopsy", which is meant to detect cancers by sequencing the DNA in a few drops of a person's blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation.

cf-DNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the cf-DNA originates from tumoral tissue. This, and the fact that cf-DNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer. And we call the cf-DNA of tumor as ct-DNA.

Peripheral blood mononuclear cells (PBMC) is any peripheral blood cell having a round nucleus. These cells can be extracted from whole blood using ficoll, a hydrophilic polysaccharide. PBMC contains genetic material of tumor and may be applied as a biomarker.

This study aims to evaluate the role of ct-DNA and PBMC as biomarkers in the treatment of biliary tract cancer.


Sponsor: RenJi Hospital

Current Primary Outcome: Pathological diagnosis of gallbladder polyps （Cholesterol / Adenoma / Others） [ Time Frame: intraoperative ]

Sensitivity and specificity


Original Primary Outcome: Diagnostic performance [ Time Frame: intraoperative ]

Sensitivity and specificity


Current Secondary Outcome: Tumor status （worse/ maintain/ better） [ Time Frame: 3 years ]

the level of ct-DNA compared with the tumor burden


Original Secondary Outcome: Tumor burden [ Time Frame: 3 years ]

the level of ct-DNA compared with the tumor burden


Information By: RenJi Hospital

Dates:
Date Received: June 20, 2016
Date Started: July 2016
Date Completion: July 2019
Last Updated: August 25, 2016
Last Verified: August 2016