The Metabolomics of Intestinal Polyps of Different Pathological Types and TCM Syndromes and TCM Constitution Types

February 16, 2020 updated by: Wei Xu, First Affiliated Hospital of Harbin Medical University
The aim of this study is to confirm the TCM syndrome types and TCM constitution classifications of the patients with intestinal polyps via on-site epidemiological survey, to analyze metabolomics of the serum samples of intestinal polyps and healthy volunteers, and to study the metabolomics differences of the two populations and the metabolomics variations of the patients with intestinal polyps of pre-polypectomy and post-polypectomy. Finally, this study is to investigate the serum metabolomics variations of patients with intestinal polyps of pre-polypectomy and post-polypectomy and the relationship with their TCM syndrome types and TCM constitution classifications, to determine the correlation among pathology, TCM constitution, TCM syndrome types and the metabonomics variations of patients with intestinal polyps.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1659

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The First Affiliated Hospital Of Harbin Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intestinal polyps patients

Description

Inclusion Criteria:

  1. Age 20 to 80,all genders;
  2. Intestinal polyps were found by colonoscopy;
  3. The patients are scheduled for polypectomy;
  4. Preoperative examinations were completed;
  5. Performance status 0-1;
  6. Diet has well controlled prior to the operation;
  7. Patients or their statutory agent have signed the informed consent forms.

Exclusion Criteria:

  1. The patient has not diagnosed by colonoscopy;
  2. The patient has surgical contraindication;
  3. Patients in pregnant or lactational period ;
  4. Psychopath;
  5. The patient is in drug trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intestinal Polyps
The patients who were diagnosed with Intestinal Polyps.
Other: No intervention
Normal colonoscopy
People who were diagnosed by colonoscopy without intestinal polyps.
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aiming to obtain biomarker groups of different pathological types of intestinal polyps, The potential biomarkers will be entered KEGG database to obtain metabolic pathways.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
All data matrices are introduced to Ezinfo software for PCA and OPLS-DA. Using improved "MetPA enriched pathways" method to discover the metabolic pathways of the disease.
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Harbin Medical University

Collaborators

Heilongjiang University of Chinese Medicine

Investigators

  • Principal Investigator: Wei Xu, Doctor, First Affiliated Hospital of Harbin Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2016

Primary Completion (Actual)

January 21, 2019

Study Completion (Actual)

February 19, 2019

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 16, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wei Xu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intestinal Polyps

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe