CompletedNCT02986308Updated Feb 18, 2020

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

An observational study in Intestinal Polyps, sponsored by First Affiliated Hospital of Harbin Medical University. Completed at 1 site in China. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-18.

Sponsored by First Affiliated Hospital of Harbin Medical University · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 1,659
Ages: 20 Years to 80 Years
Sex: All

Study 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 studied

Intestinal Polyps

Browse trials for

Polyps 385

Keywords

Metabolomics
Intestinal Polyps
TCM Syndromes
TCM Constitution Types

In context

Polyps

385 studies on the registry are indexed under Polyps; 59 are open to participants now.

This study's enrollment of 1,659 is above the median of 271 across 128 observational studies indexed under Polyps.

Browse Polyps studies →

Lead sponsor

First Affiliated Hospital of Harbin Medical University is the lead sponsor of 73 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Intestinal polyps patients

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 1,659 participants (actual)
Target follow-up: 10 Days
Patient registry: Yes
Biospecimen retention: Samples with dna

Groups and cohorts

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

OtherNo intervention

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150001, China

References and documents

Publications

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. PubMed 31784934 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02986308
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Collaborators: Heilongjiang University of Chinese Medicine
Responsible party: Wei Xu (MD,Professor, First Affiliated Hospital of Harbin Medical University) — Principal investigator
First posted: Dec 8, 2016
Start date: Jun 13, 2016
Primary completion: Jan 21, 2019
Completion: Feb 19, 2019
Last update: Feb 18, 2020

Study contacts

Wei Xu, Doctor

principal investigator · First Affiliated Hospital of Harbin Medical University

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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