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MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400657
Recruitment Status : Unknown
Verified January 2018 by Shen Lin, Peking University.
Recruitment status was:  Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Multi-disciplinary Treatment Procedure: Multi-disciplinary Treatment

Study Design
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Study Type : Observational
Estimated Enrollment : 484 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
fully implemented to the MDT decision
group of patients fully implemented to the MDT decision
 Procedure: Multi-disciplinary Treatment
due to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery.
not completly implemented to the MDT-decision
group of patients not completly implemented to the MDT decision
 Procedure: Multi-disciplinary Treatment
due to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery.
not implemented to the MDT decision
group of patients not implemented to the MDT decision
 Procedure: Multi-disciplinary Treatment
due to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Differences in overall survival after performing MDT at center [ Time Frame: 1 years ]
    Differences in overall survival after performing MDT at center


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
recurrent / metastatic gastric or colorectal cancer
Criteria

Inclusion Criteria:

  1. Histopathological diagnosis of recurrent / metastatic gastric or colorectal cancer.
  2. Participate in formal MDT discussions at the Research Center.
  3. MDT decision-making at least two subjects involved in treatment.
  4. Patient informed consent and signed written consent.

Exclusion Criteria:

  1. Early or locally advanced gastric cancer or colorectal cancer.
  2. Accept informal MDT discussions.
  3. MDT decisions recommend only a single subject for treatment of patients.
  4. MDT decisions recommend only palliative patients.
Contacts and Locations
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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): NCT03400657


Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
More Information
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Responsible Party: Shen Lin, Head of department of Gastroentestinal oncology, Peking University
ClinicalTrials.gov Identifier: NCT03400657    
Other Study ID Numbers: CSMDT-01
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
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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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases