Precise Treatment System of Biliary Malignancies Based on Special Disease Database

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT03499782

Collaborator

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

10,000

Enrollment

Location

43.2

Anticipated Duration (Months)

231.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholangiocarcinoma Gall Bladder Carcinoma Biliary System Disorder

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

May 25, 2018

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

Death from biliary tract carcinoma [Every three months, up to five years]
Death from cholangiocarcinoma or gallbladder carcinoma

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhaohui Tang	Shanghai	Shanghai	China	200092

Sponsors and Collaborators

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

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhaohui Tang, Professor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT03499782

Other Study ID Numbers:

XHEC-JDYXY-2018-002

First Posted:

Apr 17, 2018

Last Update Posted:

Apr 17, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zhaohui Tang, Professor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Prognosis

Surgery options

Bayesian networks

Additional relevant MeSH terms:

Cholangiocarcinoma

Urinary Bladder Neoplasms

Study Results

No Results Posted as of Apr 17, 2018