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Study on the Correlation Between Gene Mutation and TCM Syndrome Types in Metastatic 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. 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: NCT04661046
Recruitment Status : Not yet recruiting
First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

Study Description
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Brief Summary:
To explore the correlation between gene mutations of metastatic colorectal cancer and TCM syndrome types based on Second-generation sequencing technology.

Condition or disease Intervention/treatment Phase
Gene Mutation-Related Cancer Traditional Chinese Medicine Drug: Traditional Chinese Medicine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Study on the Correlation Between Gene Mutation and TCM Syndrome Types in Metastatic Colorectal Cancer
Estimated Study Start Date : November 30, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TCM Syndrome Types
Traditional Chinese Medicine
 Drug: Traditional Chinese Medicine
Chinese medicine prescription
Other Name: TCM


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]
    OS

  2. Progression Free Survival [ Time Frame: 2 years ]
    PFS


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A clear pathological diagnosis is a patient with colorectal cancer;
  2. Have complete TNM staging information;
  3. There is a clear diagnosis of the location and time of metastasis;
  4. Age ≥18 years old, ≤80 years old, male or female;
  5. There is a clear time for the first treatment with Chinese medicine;
  6. Patients who can receive long-term follow-up. -

Exclusion Criteria:

  1. Patients with colorectal cancer diagnosed pathologically as adenosquamous carcinoma, squamous cell carcinoma, carcinoid, small cell carcinoma, malignant lymphoma, etc.;
  2. Patients with double cancer, multiple or metastatic colorectal cancer;
  3. Combined with severe acute and chronic diseases that may affect treatment and prognosis, such as myocardial infarction, stroke, severe renal insufficiency and mental illness;-
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT04661046    
Other Study ID Numbers: SHSLCZDZK 03701
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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