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

NCT02986308 | Completed

• 1 other identifier: Wei Xu
• Study Type: observational
• Target: 1,659
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intestinal Polyps

Keywords

Metabolomics; Intestinal Polyps; TCM Syndromes; TCM Constitution Types

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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

Interventions

No intervention OTHER

Intestinal Polyps; Normal colonoscopy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intestinal polyps patients

You may qualify if:

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

You may not qualify if:

• The patient has not diagnosed by colonoscopy;
• The patient has surgical contraindication;
• Patients in pregnant or lactational period ;
• Psychopath;
• The patient is in drug trial.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead
• Heilongjiang University of Chinese Medicine: collaborator

Study Sites (1)

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Related Publications (1)

• Du WZ, Zhang AH, Ren JL, Lyu K, Tuo LY, Xu W. Study of Differential Serum Metabolites in Patients with Adenomatous Polyps of Colon and Yang-Deficiency Constitution Based on Ultra-Performance Liquid Chromatography-Mass Spectrometry. Chin J Integr Med. 2022 May;28(5):403-409. doi: 10.1007/s11655-019-3181-9. Epub 2019 Nov 29.

  PMID: 31784934 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Intestinal Polyps

Condition Hierarchy (Ancestors)

Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Xu, Doctor

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Professor

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: December 8, 2016
• Study Start: June 13, 2016
• Primary Completion: January 21, 2019
• Study Completion: February 19, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)