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Clinical Trials/NCT03892252
NCT03892252
Completed
Not Applicable

Correlation Analysis of TCM Syndromes, TCM Constitution Types, Intestinal Microbial Evolution and Tumor Biological Characteristics in Colorectal Cancer Patients Before and After Surgery

Wei Xu1 site in 1 country192 target enrollmentMarch 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Neoplasms
Sponsor
Wei Xu
Enrollment
192
Locations
1
Primary Endpoint
According to the 16s rDNA sequencing results, analyze the differences in intestinal flora of colon cancer patients with different TCM syndromes and TCM constitutions before and after surgery and their correlations
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Guided by the idea of combining disease differentiation with syndrome differentiation in traditional Chinese medicine, this study used the form of questionnaire to summarize the changes of TCM syndromes, TCM constitution types in colorectal cancer patients before and after surgery. The Next-generation sequencing technology was used to explore the changes and differences of intestinal microorganisms before and after surgery. The correlation between changes of TCM syndromes, TCM constitution types, intestinal microbial evolution and tumor biological characteristics in colorectal cancer patients before and after surgery was analyzed. To explore the rationality of TCM in the prevention and treatment of colorectal cancer recurrence and metastasis in order to guide the individualized treatment and dietary regulation of TCM.

Registry
clinicaltrials.gov
Start Date
March 10, 2019
End Date
February 20, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Wei Xu
Responsible Party
Sponsor Investigator
Principal Investigator

Wei Xu

Professor

First Affiliated Hospital of Harbin Medical University

Eligibility Criteria

Inclusion Criteria

  • Preoperative abdominal CT, colonoscopy and pathological examination were diagnosed as colorectal malignant tumor patients;
  • Having surgical indications;
  • Patients who were not treated with antibiotics or microbiological agents one week before surgery;
  • Patients who had not received radiotherapy and chemotherapy before surgery;
  • Patients or their legal representatives informed and agreed to participate in this clinical trial and signed a written informed consent;

Exclusion Criteria

  • Have other cancer history;
  • Patients who have received invasive treatment within the past three months;
  • Inflammatory bowel disease such as ulcerative colitis or crohn's disease;
  • Combined with intestinal obstruction or intestinal perforation for emergency surgery;
  • Psychiatric history, can not join and standardize the completion of clinical investigators;
  • Pregnant or nursing women;
  • Patients treated with antibiotics or microbiological agents one week before surgery;
  • People have incomplete data;

Outcomes

Primary Outcomes

According to the 16s rDNA sequencing results, analyze the differences in intestinal flora of colon cancer patients with different TCM syndromes and TCM constitutions before and after surgery and their correlations

Time Frame: 1 month

According to the 16s rDNA sequencing results, characterize the intestinal microbiota characteristics of colon cancer patients with different TCM syndrome types and TCM constitutions before and after surgery

Time Frame: 2 year

Study Sites (1)

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