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

Intestinal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986308
• Other study ID #: Wei Xu
• Status: Completed
• Start date: June 13, 2016
• Est. completion date: February 19, 2019

Study information

• Verified date: February 2020
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1659
• Est. completion date: February 19, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Polyps
• Polyps

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University	Heilongjiang University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aiming to obtain biomarker groups of different pathological types of intestinal polyps, The potential biomarkers will be entered KEGG database to obtain metabolic pathways.		2 years
Secondary	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.		3 days