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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02809898
Enrollment
30
Registered
2016-06-22
Start date
2016-07-31
Completion date
2020-12-31
Last updated
2019-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Neoplasms

Keywords

Biomarkers, Neoplasms

Brief summary

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

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.

Interventions

Do radical surgery or biopsy to obtain a pathological result

Sponsors

Huadong Hospital
CollaboratorOTHER
Shanghai Changzheng Hospital
CollaboratorOTHER
Yangpu District Central Hospital Affiliated to Tongji University
CollaboratorOTHER
RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pathological diagnosis of gallbladder polyps (Cholesterol / Adenoma / Others)intraoperativeSensitivity and specificity

Secondary

MeasureTime frameDescription
Tumor status (worse/ maintain/ better)3 yearsthe level of ct-DNA compared with the tumor burden

Countries

China

Contacts

Primary ContactTao Chen, M.D.
dr_chentao78@163.com+8613601779874
Backup ContactYunhe Zhang, M.D.
zyhe31@163.com+8613917908722

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026