Precise Treatment System of Biliary Malignancies Based on Special Disease Database

NCT03499782 | Unknown DMC

• 1 other identifier: XHEC-JDYXY-2018-002
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholangiocarcinoma; Gall Bladder Carcinoma; Biliary System Disorder

Keywords

Prognosis; Surgery options; Bayesian networks

Outcome Measures

Primary Outcomes (1)

• Death from biliary tract carcinoma

  Death from cholangiocarcinoma or gallbladder carcinoma

  Every three months, up to five years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients Diagnosed with Gallbladder carcinoma or cholangiocarcinoma

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Zhaohui Tang

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Gallbladder Neoplasms; Gallbladder Diseases

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• 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 DIRECTOR

Central Study Contacts

Zhaohui Tang, MD,PhD

CONTACT

+86 13601789458; tangzhaohui@yahoo.com

Miaoyan Wei, MD,PhD

CONTACT

+86 18516574578; doctor_vmy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: April 17, 2018
• Study Start: May 25, 2018
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

CN (1)