CholangiocarcinomaNCT04243057
Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study
An observational study of Cholangiocarcinoma, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2019to 30 Sep 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from 21 hospitals limit:5000
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
JiaHong Dong, MD, 01056118763, dongjiahong@mail.tsinghua.edu.cn
About this study
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
- Conditions
- Cholangiocarcinoma
- Medical subject headings
- Cholangiocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
RFSR
RFSR-Recurrence Free Survival Rate
Measured: 3 years
Secondary outcomes (2)
OS
OS-Overall Survival
Measured: 3 years
RFS
RFS-Recurrence Free Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start30 Aug 2019
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jiahong, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243057
- Sponsor's protocol ID
- RWS-BTCH-001
- Status last verified
- Jan 2020
- First submitted
- 24 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study
- ClinicalTrials.gov ID
- NCT04243057
- Acronym / sponsor ID
- RWS-BTCH-001
- Conditions
- Cholangiocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from 21 hospitals limit:5000
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RFSR
Time frame: 3 years
RFSR-Recurrence Free Survival Rate
2 secondary outcomes
OS
Time frame: 3 years
RFS
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaobin Feng, MD (+86 16601111975, fengxiaobin200708@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RFSR (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.