Intestinal PolypsNCT02986308
The Metabolomics of Intestinal Polyps of Different Pathological Types and TCM Syndromes and TCM Constitution Types
An observational study of Intestinal Polyps, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Polyps
- How many people
- 1,659 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2016to 19 Feb 2019
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Intestinal polyps patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
About this study
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
- Being tested
- No intervention
- Keywords
- Metabolomics, Intestinal Polyps, TCM Syndromes, TCM Constitution Types
- Medical subject headings
- Intestinal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Intestinal Polyps | The patients who were diagnosed with Intestinal Polyps. Receives: Other: No intervention | |
| Normal colonoscopy | People who were diagnosed by colonoscopy without intestinal polyps. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aiming to obtain biomarker groups of different pathological types of intestinal polyps, The potential biomarkers will be entered KEGG database to obtain metabolic pathways.
Measured: 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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start13 Jun 2016
- Primary completion21 Jan 2019
- Study completion19 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,659 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Heilongjiang University of Chinese Medicine
- Responsible party
- Principal investigator, Wei Xu, First Affiliated Hospital of Harbin Medical University
- Investigators
- Wei Xu, Doctor, Principal investigator, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986308
- Sponsor's protocol ID
- Wei Xu
- Status last verified
- Feb 2020
- First submitted
- 1 Aug 2016
- Last updated
- 18 Feb 2020
- Results posted
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolomics of Intestinal Polyps of Different Pathological Types and TCM Syndromes and TCM Constitution Types
- ClinicalTrials.gov ID
- NCT02986308
- Acronym / sponsor ID
- Wei Xu
- Conditions
- Intestinal Polyps
- Keywords
- Metabolomics, Intestinal Polyps, TCM Syndromes, TCM Constitution Types
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,659 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- Heilongjiang University of Chinese Medicine
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intestinal Polyps | – | Other: No interventionThe patients who were diagnosed with Intestinal Polyps. |
| Normal colonoscopy | – | Other: No interventionPeople who were diagnosed by colonoscopy without intestinal polyps. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Intestinal polyps patients
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Intestinal Polyps, Normal colonoscopy |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Derived from this study: PubMed 31784934Du 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xu, Doctor principal investigator
First Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Polyps, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02986308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.