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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243057
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Dong Jiahong, Beijing Tsinghua Chang Gung Hospital

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

Condition or disease
Cholangiocarcinoma

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 3 Years
Official Title: Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. RFSR [ Time Frame: 3 years ]
    RFSR-Recurrence Free Survival Rate


Secondary Outcome Measures :
  1. OS [ Time Frame: 3 years ]
    OS-Overall Survival

  2. RFS [ Time Frame: 3 years ]
    RFS-Recurrence Free Survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from 21 hospitals limit:5000
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243057


Contacts
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Contact: Xiaobin Feng, MD +86 16601111975 fengxiaobin200708@aliyun.com

Locations
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China, Beijing
Beijing Tsinghua Changgung Hospital Recruiting
Beijing, Beijing, China, 102218
Contact: JiaHong Dong, MD    01056118763    dongjiahong@mail.tsinghua.edu.cn   
Sponsors and Collaborators
Beijing Tsinghua Chang Gung Hospital
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Responsible Party: Dong Jiahong, Executive President of Beijing Tsinghua Changgung Hospital, Beijing Tsinghua Chang Gung Hospital
ClinicalTrials.gov Identifier: NCT04243057    
Other Study ID Numbers: RWS-BTCH-001
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms