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
1 other identifier
observational
30
1 country
4
Brief Summary
Our study aims to evaluate the role of ct-DNA and PBMC as biomarkers in the treatment of biliary tract cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2016
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 22, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedOctober 17, 2019
October 1, 2019
4.4 years
June 20, 2016
October 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathological diagnosis of gallbladder polyps （Cholesterol / Adenoma / Others）
Sensitivity and specificity
intraoperative
Secondary Outcomes (1)
Tumor status （worse/ maintain/ better）
3 years
Interventions
Do radical surgery or biopsy to obtain a pathological result
Eligibility Criteria
Patients with suspected biliary tract cancer.
You may qualify if:
- Patients with suspected biliary tract cancer
- Age from 18 - 70 years
- No serious organic and mental illness;
You may not qualify if:
- Pregnancy
- No pathologic result
- Suffering other malignancies at the same time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
- Huadong Hospitalcollaborator
- Shanghai Changzheng Hospitalcollaborator
- Yangpu District Central Hospital Affiliated to Tongji Universitycollaborator
Study Sites (4)
Huadong Hospital
Shanghai, 200000, China
Shanghai Yangpu district central hospital
Shanghai, 200000, China
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
Shanghai Changzheng Hospital
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tao Chen, M.D.
Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2016
First Posted
June 22, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
October 17, 2019
Record last verified: 2019-10