Multi-disciplinary TreatmentNCT03400657
MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer
An observational study of Multi-disciplinary Treatment, run by Peking University at 1 site in China.
Trial summary
This is a prospective, multicenter, non-interventional, controlled clinical study. Evaluate MDT performance and benefit analysis in patients with advanced gastric or colorectal cancer after MDT discussion under real medical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multi-disciplinary Treatment
- What is being tested?
- Multi-disciplinary Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 484 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: recurrent / metastatic gastric or colorectal cancer
Who may be able to join
- Histopathological diagnosis of recurrent / metastatic gastric or colorectal cancer.
- Participate in formal MDT discussions at the Research Center.
- MDT decision-making at least two subjects involved in treatment.
- Patient informed consent and signed written consent.
Who cannot join
- Early or locally advanced gastric cancer or colorectal cancer.
- Accept informal MDT discussions.
- MDT decisions recommend only a single subject for treatment of patients.
- MDT decisions recommend only palliative patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Prospective, Non-intervention, Controlled Trial of MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer in Realistic Medical Practice
This is a prospective, multicenter, non-interventional, controlled clinical study. Evaluate MDT performance and benefit analysis in patients with advanced gastric or colorectal cancer after MDT discussion under real medical practice.
- Conditions
- Multi-disciplinary Treatment
- Being tested
- Multi-disciplinary Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-disciplinary TreatmentProcedure or surgery
due to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery.
| Study group | Role | What they receive |
|---|---|---|
| fully implemented to the MDT decision | group of patients fully implemented to the MDT decision Receives: Procedure: Multi-disciplinary Treatment | |
| not completly implemented to the MDT-decision | group of patients not completly implemented to the MDT decision Receives: Procedure: Multi-disciplinary Treatment | |
| not implemented to the MDT decision | group of patients not implemented to the MDT decision Receives: Procedure: Multi-disciplinary Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (1)
Differences in overall survival after performing MDT at center
Differences in overall survival after performing MDT at center
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Nov 2017
- Primary completionJan 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-disciplinary TreatmentStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400657
- Sponsor's protocol ID
- CSMDT-01
- Status last verified
- Jan 2018
- First submitted
- 2 Jan 2018
- Last updated
- 17 Jan 2018
- Results posted
- 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 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Prospective, Non-intervention, Controlled Trial of MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer in Realistic Medical Practice
- ClinicalTrials.gov ID
- NCT03400657
- Acronym / sponsor ID
- CSMDT-01
- Conditions
- Multi-disciplinary Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 17 Jan 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.
This is a prospective, multicenter, non-interventional, controlled clinical study. Evaluate MDT performance and benefit analysis in patients with advanced gastric or colorectal cancer after MDT discussion under real medical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fully implemented to the MDT decision | – | Procedure: Multi-disciplinary Treatmentgroup of patients fully implemented to the MDT decision |
| not completly implemented to the MDT-decision | – | Procedure: Multi-disciplinary Treatmentgroup of patients not completly implemented to the MDT decision |
| not implemented to the MDT decision | – | Procedure: Multi-disciplinary Treatmentgroup of patients not implemented to the MDT decision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- recurrent / metastatic gastric or colorectal cancer
Key inclusion criteria (4 listed)
- Histopathological diagnosis of recurrent / metastatic gastric or colorectal cancer.
- Participate in formal MDT discussions at the Research Center.
- MDT decision-making at least two subjects involved in treatment.
- Patient informed consent and signed written consent.
Key exclusion criteria (4 listed)
- Early or locally advanced gastric cancer or colorectal cancer.
- Accept informal MDT discussions.
- MDT decisions recommend only a single subject for treatment of patients.
- MDT decisions recommend only palliative patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-disciplinary Treatmentdue to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery. | Procedure or surgery | fully implemented to the MDT decision, not completly implemented to the MDT-decision, not implemented to the MDT decision |
Primary outcome
overall survival
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
1 secondary outcome
Differences in overall survival after performing MDT at center
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Multi-disciplinary Treatment, run by Peking University 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 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 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). 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 Jan 2018.