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Completed

NCT Number: NCT03892252

Characteristics of Gut Microbiota in Patients With Colon Cancer of Different Traditional Chinese Medicine Syndromes

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Wei Xu

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 27, 2019
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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