NCT04243057

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:

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3.1 years

First QC Date

January 24, 2020

Last Update Submit

January 24, 2020

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • RFSR

    RFSR-Recurrence Free Survival Rate

    3 years

Secondary Outcomes (2)

  • OS

    3 years

  • RFS

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from 21 hospitals limit:5000

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Xiaobin Feng, MD

CONTACT

+86 16601111975fengxiaobin200708@aliyun.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive President of Beijing Tsinghua Changgung Hospital

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 27, 2020

Study Start

August 30, 2019

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)