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NCT Number: NCT02986308

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

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

No intervention

Other

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.

    Time frame: 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.

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Harbin Medical University

Other

Collaborators

  • Heilongjiang University of Chinese Medicine

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 8, 2016
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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