Precise Treatment System of Biliary Malignancies Based on Special Disease Database

April 13, 2018 updated by: Zhaohui Tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

A Multi-center Study：Surgical Optimization and Prognosis Auxiliary System of Biliary Malignancies Based on Special Disease Database

Malignant tumors of biliary system lack standard treatment and precise prognosis assessment methods. This study including 12 hospitals, collecting clinical and follow-up data of patients with biliary malignant tumors including cholangiocarcinoma and gallbladder carcinoma in recent 10 years, aim to build a special disease database, then use Bayesian networks and importance theory to establish a mathematical model to assess treatment strategies and prognosis accurately. At the same time, data on biliary malignant tumors newly treated by multicenters from 2018 to 2020 will be included to validate, adjust and refine the models to guide clinical individualized precise treatment.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients Diagnosed with Gallbladder carcinoma or cholangiocarcinoma

Description

Inclusion Criteria：

  • Clinical diagnosis of biliary malignancy including gallbladder carcinoma or cholangiocarcinoma verified by pathological results
  • Must be able to undergo surgery
  • Undergoing radical surgery for biliary malignancy (R0 or R1 resection)
  • Not complicated with other malignancy
  • No other treatments before and during surgery, such as radiotherapy and chemotherapy.

Exclusion Criteria:

  • Non-primary gallbladder or cholangiocarcinoma
  • With distant metastasis (M1 phase)
  • Incomplete follow-up data
  • Died within 30 days after surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death from biliary tract carcinoma
Time Frame: Every three months, up to five years
Death from cholangiocarcinoma or gallbladder carcinoma
Every three months, up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Sun Yat-sen University
Shanghai Zhongshan Hospital
Southwest Hospital, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital Xi'an Jiaotong University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Tianjin Medical University Cancer Institute and Hospital
The First Affiliated Hospital of Zhengzhou University
Eastern Hepatobiliary Surgery Hospital
The First Affiliated Hospital of Dalian Medical University
Affiliated Hospital of North Sichuan Medical College

Investigators

  • Study Director: Zhimin Geng, MD,PhD, the first affiliated hospital of xi'an Jiaotong univerisity
  • Study Director: Peng Gong, MD,PhD, the first affiliated hospital of Dalian medical univerisity
  • Study Director: Yu He, MD,PhD, Southwest Hospital, China
  • Study Director: Shengping Li, MD,PhD, Cancer Institute and Hospital Affiliated to Sun Yat-sen University
  • Study Director: Yinghe Qiu, MD,PhD, Eastern Hepatobiliary Surgery Hospital
  • Study Director: Zhi Dai, MD,PhD, Shanghai Zhongshan Hospital
  • Study Director: Tianqiang Song, MD,PhD, Tianjin Medical University Cancer Institute and Hospital
  • Study Director: Yudong Qiu, MD,PhD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Study Director: Jianying Lou, MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Study Director: Jingdong Li, MD,PdD, Affliated Hospital of North Sichuan Medical College
  • Study Director: Wenlong Zhai, MD,PhD, The First Affiliated Hospital of Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 25, 2018

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 8, 2018

First Submitted That Met QC Criteria

April 13, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHEC-JDYXY-2018-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholangiocarcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe