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

Biliary Tract Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02809898
• Other study ID #: cfDNA-GCCC
• Status: Recruiting
• Start date: July 2016
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: RenJi Hospital
• Contact: Tao Chen, M.D.
• Phone: +8613601779874
• Email: dr_chentao78[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Huadong Hospital	Shanghai
China	Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai
China	Shanghai Changzheng Hospital	Shanghai
China	Shanghai Yangpu district central hospital	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
RenJi Hospital	Huadong Hospital, Shanghai Changzheng Hospital, Yangpu District Central Hospital Affiliated to Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological diagnosis of gallbladder polyps (Cholesterol / Adenoma / Others)	Sensitivity and specificity	intraoperative
Secondary	Tumor status (worse/ maintain/ better)	the level of ct-DNA compared with the tumor burden	3 years