CholangiocarcinomaNCT03499782
Precise Treatment System of Biliary Malignancies Based on Special Disease Database
An observational study of Cholangiocarcinoma and Gall Bladder Carcinoma, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholangiocarcinoma, Gall Bladder Carcinoma, Biliary System Disorder
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2018to 31 Dec 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients Diagnosed with Gallbladder carcinoma or cholangiocarcinoma
Who may be able to join
- 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.
Who cannot join
- Non-primary gallbladder or cholangiocarcinoma
- With distant metastasis (M1 phase)
- Incomplete follow-up data
- Died within 30 days after surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhaohui Tang
Shanghai, Shanghai Municipality, 200092
Miaoyan Wei, +86 18516574578, doctor_vmy@163.com
Zhaohiu Tang Tang, +8613601789458, tangzhaohui@yahoo.com
About this study
Official title: A Multi-center Study：Surgical Optimization and Prognosis Auxiliary System of Biliary Malignancies Based on Special Disease Database
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.
- Keywords
- Prognosis, Surgery options, Bayesian networks
- Medical subject headings
- Cholangiocarcinoma, Gallbladder Neoplasms, Gallbladder Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from biliary tract carcinoma
Death from cholangiocarcinoma or gallbladder carcinoma
Measured: Every three months, up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start25 May 2018 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2021 (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 Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Zhejiang University, School of Medicine, Eastern Hepatobiliary Surgery Hospital
- Responsible party
- Principal investigator, Zhaohui Tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhimin Geng, MD,PhD, Study director, the first affiliated hospital of xi'an Jiaotong univerisityPeng Gong, MD,PhD, Study director, the first affiliated hospital of Dalian medical univerisityYu He, MD,PhD, Study director, Southwest Hospital, ChinaShengping Li, MD,PhD, Study director, Cancer Institute and Hospital Affiliated to Sun Yat-sen UniversityYinghe Qiu, MD,PhD, Study director, Eastern Hepatobiliary Surgery HospitalZhi Dai, MD,PhD, Study director, Shanghai Zhongshan HospitalTianqiang Song, MD,PhD, Study director, Tianjin Medical University Cancer Institute and HospitalYudong Qiu, MD,PhD, Study director, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499782
- Sponsor's protocol ID
- XHEC-JDYXY-2018-002
- Status last verified
- Apr 2018
- First submitted
- 8 Apr 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study：Surgical Optimization and Prognosis Auxiliary System of Biliary Malignancies Based on Special Disease Database
- ClinicalTrials.gov ID
- NCT03499782
- Acronym / sponsor ID
- XHEC-JDYXY-2018-002
- Keywords
- Prognosis, Surgery options, Bayesian networks
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- 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, Zhejiang University, School of Medicine, Eastern Hepatobiliary Surgery Hospital
- Study start
- 25 May 2018 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Apr 2018 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Diagnosed with Gallbladder carcinoma or cholangiocarcinoma
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Non-primary gallbladder or cholangiocarcinoma
- With distant metastasis (M1 phase)
- Incomplete follow-up data
- Died within 30 days after surgery.
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
Death from biliary tract carcinoma
Time frame: Every three months, up to five years
Death from cholangiocarcinoma or gallbladder carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Zhimin Geng, MD,PhD study director
the first affiliated hospital of xi'an Jiaotong univerisity
Peng Gong, MD,PhD study director
the first affiliated hospital of Dalian medical univerisity
Yu He, MD,PhD study director
Southwest Hospital, China
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 and Gall Bladder Carcinoma, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 4 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 17 Apr 2018. 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 Zhaohui Tang, MD,PhD (+86 13601789458, tangzhaohui@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from biliary tract carcinoma (time frame: Every three months, up to five 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 17 Apr 2018.