The Role of ctDNA and PBMC in Treatment of Biliary Tract Cancer
Study Details
Study Description
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 | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Pathological diagnosis of gallbladder polyps （Cholesterol / Adenoma / Others） [intraoperative]
Sensitivity and specificity
Secondary Outcome Measures
- Tumor status （worse/ maintain/ better） [3 years]
the level of ct-DNA compared with the tumor burden
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with suspected biliary tract cancer
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Age from 18 - 70 years
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No serious organic and mental illness;
Exclusion Criteria:
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Pregnancy
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No pathologic result
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Suffering other malignancies at the same time.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huadong Hospital | Shanghai | China | 200000 | |
| 2 | Shanghai Yangpu district central hospital | Shanghai | China | 200000 | |
| 3 | Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | China | ||
| 4 | Shanghai Changzheng Hospital | Shanghai | China |
Sponsors and Collaborators
- RenJi Hospital
- Huadong Hospital
- Shanghai Changzheng Hospital
- Yangpu District Central Hospital Affiliated to Tongji University
Investigators
- Principal Investigator: Tao Chen, M.D., Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- cfDNA-GCCC