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The Role of ctDNA and PBMC in Treatment of Biliary Tract Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02809898
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : October 17, 2019
Sponsor:
Collaborators:
Huadong Hospital
Shanghai Changzheng Hospital
Yangpu District Central Hospital Affiliated to Tongji University
Information provided by (Responsible Party):
RenJi Hospital

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

Condition or disease Intervention/treatment
Biliary Tract Neoplasms Procedure: surgery or biopsy

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: surgery or biopsy
    Do radical surgery or biopsy to obtain a pathological result


Primary Outcome Measures :
  1. Pathological diagnosis of gallbladder polyps (Cholesterol / Adenoma / Others) [ Time Frame: intraoperative ]
    Sensitivity and specificity


Secondary Outcome Measures :
  1. Tumor status (worse/ maintain/ better) [ Time Frame: 3 years ]
    the level of ct-DNA compared with the tumor burden



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected biliary tract cancer.
Criteria

Inclusion Criteria:

  • Patients with suspected biliary tract cancer
  • Age from 18 - 70 years
  • No serious organic and mental illness;

Exclusion Criteria:

  • Pregnancy
  • No pathologic result
  • Suffering other malignancies at the same time.

Information from the National Library of Medicine

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


Contacts
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Contact: Tao Chen, M.D. +8613601779874 dr_chentao78@163.com
Contact: Yunhe Zhang, M.D. +8613917908722 zyhe31@163.com

Locations
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China
Huadong Hospital Not yet recruiting
Shanghai, China, 200000
Contact: Wei Wang, MD       wangw2003cn@hotmail.com   
Shanghai Yangpu district central hospital Recruiting
Shanghai, China, 200000
Contact: Min Tang, MD    13611673551    tommy1086@sohu.com   
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, China
Contact: Tao Chen, MD.       dr_chentao78@163.com   
Shanghai Changzheng Hospital Not yet recruiting
Shanghai, China
Contact: Chenghao Shao, MD    13801938229    13801938229@163.com   
Sponsors and Collaborators
RenJi Hospital
Huadong Hospital
Shanghai Changzheng Hospital
Yangpu District Central Hospital Affiliated to Tongji University
Investigators
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Principal Investigator: Tao Chen, M.D. Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02809898    
Other Study ID Numbers: cfDNA-GCCC
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by RenJi Hospital:
Biomarkers, Neoplasms
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases