NCT03892252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

March 14, 2019

Last Update Submit

September 22, 2021

Conditions

Colorectal Neoplasms

Keywords

gut microbiota16s rDNA sequebcingTCM sydromesTCM Constitution Types

Outcome Measures

Primary Outcomes (2)

  • 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

    2 year

  • 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

    1 month

Study Arms (3)

before surgery

no intervention(s)

Other: No intervention

after surgery

no intervention(s)

Other: No intervention

Normal colonoscopy

People who were diagnosed by colonoscopy without colorectal cancer.

Other: No intervention

Interventions

No interventionOTHER

No intervention

Normal colonoscopyafter surgerybefore surgery

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Colorectal cancer patients admitted to the first affiliated hospital of Harbin medical university

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

fecal

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Wei Xu, Professor

    First Affiliated Hospital of Harbin Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 27, 2019

Study Start

March 10, 2019

Primary Completion

February 1, 2020

Study Completion

February 20, 2020

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

CN(1)