Clinical trial NCT03892252: Characteristics of Gut Microbiota in Patients With Colon Cancer of Different Traditional Chinese Medicine Syndromes
Official title: Correlation Analysis of TCM Syndromes, TCM Constitution Types, Intestinal Microbial Evolution and Tumor Biological Characteristics in Colorectal Cancer Patients Before and After Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: gut microbiota
16s rDNA sequebcing
TCM sydromes
TCM Constitution Types
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 192
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal cancer patients admitted to the first affiliated hospital of Harbin medical university

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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
timeFrame: 2 year
measure: 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
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Wei Xu, Professor
role: PRINCIPAL_INVESTIGATOR
References: