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

NCT ID: NCT02809898

Last Updated: 2019-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Biliary Tract Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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surgery or biopsy

Do radical surgery or biopsy to obtain a pathological result

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huadong Hospital

OTHER

Sponsor Role collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role collaborator

Yangpu District Central Hospital Affiliated to Tongji University

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tao Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

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Huadong Hospital

Shanghai, , China

Site Status NOT_YET_RECRUITING

Shanghai Yangpu district central hospital

Shanghai, , China

Site Status RECRUITING

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, , China

Site Status RECRUITING

Shanghai Changzheng Hospital

Shanghai, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Tao Chen, M.D.

Role: CONTACT

+8613601779874

Yunhe Zhang, M.D.

Role: CONTACT

+8613917908722

Facility Contacts

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Wei Wang, MD

Role: primary

Min Tang, MD

Role: primary

13611673551

Tao Chen, MD.

Role: primary

Chenghao Shao, MD

Role: primary

13801938229

Other Identifiers

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cfDNA-GCCC

Identifier Type: -

Identifier Source: org_study_id

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