Clinical trial NCT02986308: The Metabolomics of Intestinal Polyps of Different Pathological Types and TCM Syndromes and TCM Constitution Types
Official title: The Metabolomics of Intestinal Polyps of Different Pathological Types and TCM Syndromes and TCM Constitution Types
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intestinal Polyps
Keywords: Metabolomics
Intestinal Polyps
TCM Syndromes
TCM Constitution Types
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Heilongjiang University of Chinese Medicine
First posted: 2016-12-08
Enrollment: 1659
Sex: ALL
Minimum age (years): 20
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: Intestinal polyps patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Aiming to obtain biomarker groups of different pathological types of intestinal polyps, The potential biomarkers will be entered KEGG database to obtain metabolic pathways.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 3 days
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, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.