The Role of ctDNA and PBMC in Treatment of Biliary Tract Cancer
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|ClinicalTrials.gov Identifier: NCT02809898|
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : October 17, 2019
|Condition or disease||Intervention/treatment|
|Biliary Tract Neoplasms||Procedure: surgery or biopsy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||The Role of ctDNA and PBMC as Biomarkers in Diagnostic, Efficacy Monitoring and Prognostic Evaluation of Biliary Tract Cancer|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- Procedure: surgery or biopsy
Do radical surgery or biopsy to obtain a pathological result
- Pathological diagnosis of gallbladder polyps （Cholesterol / Adenoma / Others） [ Time Frame: intraoperative ]Sensitivity and specificity
- Tumor status （worse/ maintain/ better） [ Time Frame: 3 years ]the level of ct-DNA compared with the tumor burden
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): NCT02809898
|Contact: Tao Chen, M.D.||+email@example.com|
|Contact: Yunhe Zhang, M.D.||+firstname.lastname@example.org|
|Huadong Hospital||Not yet recruiting|
|Shanghai, China, 200000|
|Contact: Wei Wang, MD email@example.com|
|Shanghai Yangpu district central hospital||Recruiting|
|Shanghai, China, 200000|
|Contact: Min Tang, MD 13611673551 firstname.lastname@example.org|
|Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University||Recruiting|
|Contact: Tao Chen, MD. email@example.com|
|Shanghai Changzheng Hospital||Not yet recruiting|
|Contact: Chenghao Shao, MD 13801938229 firstname.lastname@example.org|
|Principal Investigator:||Tao Chen, M.D.||Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University|