Diagnosis, Treatment Status and Prognosis of Cholangiocar... | NCT04243057

Studies
Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study

NCT04243057

Sponsor

Beijing Tsinghua Chang Gung Hospital

Status

Unknown status

Last Update Posted

Jan 27, 2020Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Cholangiocarcinoma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2019Actual

Primary Completion Date

Sep 30, 2022Estimated

Completion Date

Sep 30, 2022Estimated

First Submitted Date

Jan 24, 2020

First Submission Date that Met QC Criteria

Jan 24, 2020

First Posted Date

Jan 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2020

Last Update Posted Date

Jan 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dong Jiahong, Executive President of Beijing Tsinghua Changgung Hospital, Beijing Tsinghua Chang Gung HospitalPrincipal Investigator

Lead Sponsor

Beijing Tsinghua Chang Gung HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a multicenter, two-way, non-intervention study. the main purpose: Understand the current status of diagnosis and treatment of cholangiocarcinoma patients in China and observe the effect of different treatment options on patient recurrence and long-term survival

Secondary purpose:

Exploring the actual clinical treatment situation and its compliance with the existing diagnosis and treatment of bile duct cancer
Exploring the establishment of clinical research standard fields and standards for diagnosis and treatment of bile duct cancer

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RFSR	RFSR-Recurrence Free Survival Rate	3 years

Secondary Outcomes

Measure	Description	Time Frame
OS	OS-Overall Survival	3 years
RFS	RFS-Recurrence Free Survival	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

above the age of 18 years old, male or female
clinical diagnosis of patients with cholangiocarcinoma
Child-Pugh classification of A, B
Eastern Cooperative Oncology Group scoring system (ECOG) score of 0-2 points

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients from 21 hospitals limit:5000

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaobin Feng, MD	Contact	+86 16601111975		fengxiaobin200708@aliyun.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tsinghua Changgung Hospital	Recruiting	Beijing	Beijing Municipality	102218	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018281	Cholangiocarcinoma

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided