Clinical trial NCT02809898: The Role of ctDNA and PBMC in Treatment of Biliary Tract Cancer
Official title: The Role of ctDNA and PBMC as Biomarkers in Diagnostic, Efficacy Monitoring and Prognostic Evaluation of Biliary Tract Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Tract Neoplasms
Keywords: Biomarkers, Neoplasms
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Huadong Hospital
name: Shanghai Changzheng Hospital
name: Yangpu District Central Hospital Affiliated to Tongji University
First posted: 2016-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected biliary tract cancer.

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.

Eligibility 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.

Primary outcomes:
measure: Pathological diagnosis of gallbladder polyps （Cholesterol / Adenoma / Others）
timeFrame: intraoperative
Secondary outcomes:
measure: Tumor status （worse/ maintain/ better）
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huadong Hospital
city: Shanghai
country: China
facility: Shanghai Yangpu district central hospital
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
Study officials:
affiliation: Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Tao Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: