Colorectal NeoplasmsNCT03892252
Characteristics of Gut Microbiota in Patients With Colon Cancer of Different Traditional Chinese Medicine Syndromes
An observational study of Colorectal Neoplasms, run by Wei Xu at 1 site in China.
Trial summary
Guided by the idea of combining disease differentiation with syndrome differentiation in traditional Chinese medicine, this study used the form of questionnaire to summarize the changes of TCM syndromes, TCM constitution types in colorectal cancer patients before and after surgery. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2019to 20 Feb 2020
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Colorectal cancer patients admitted to the first affiliated hospital of Harbin medical university
Who may be able to join
- Preoperative abdominal CT, colonoscopy and pathological examination were diagnosed as colorectal malignant tumor patients;
- Having surgical indications;
- Patients who were not treated with antibiotics or microbiological agents one week before surgery;
- Patients who had not received radiotherapy and chemotherapy before surgery;
- Patients or their legal representatives informed and agreed to participate in this clinical trial and signed a written informed consent;
Who cannot join
- Have other cancer history;
- Patients who have received invasive treatment within the past three months;
- Inflammatory bowel disease such as ulcerative colitis or crohn's disease;
- Combined with intestinal obstruction or intestinal perforation for emergency surgery;
- Psychiatric history, can not join and standardize the completion of clinical investigators;
- Pregnant or nursing women;
- Patients treated with antibiotics or microbiological agents one week before surgery;
- People have incomplete data;
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
Official title: Correlation Analysis of TCM Syndromes, TCM Constitution Types, Intestinal Microbial Evolution and Tumor Biological Characteristics in Colorectal Cancer Patients Before and After Surgery
Guided by the idea of combining disease differentiation with syndrome differentiation in traditional Chinese medicine, this study used the form of questionnaire to summarize the changes of TCM syndromes, TCM constitution types in colorectal cancer patients before and after surgery. The Next-generation sequencing technology was used to explore the changes and differences of intestinal microorganisms before and after surgery. The correlation between changes of TCM syndromes, TCM constitution types, intestinal microbial evolution and tumor biological characteristics in colorectal cancer patients before and after surgery was analyzed. To explore the rationality of TCM in the prevention and treatment of colorectal cancer recurrence and metastasis in order to guide the individualized treatment and dietary regulation of TCM.
- Conditions
- Colorectal Neoplasms
- Being tested
- No intervention
- Keywords
- gut microbiota, 16s rDNA sequebcing, TCM sydromes, TCM Constitution Types
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| before surgery | no intervention(s) Receives: Other: No intervention | |
| after surgery | no intervention(s) Receives: Other: No intervention | |
| Normal colonoscopy | People who were diagnosed by colonoscopy without colorectal cancer. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
According to the 16s rDNA sequencing results, characterize the intestinal microbiota characteristics of colon cancer patients with different TCM syndrome types and TCM constitutions before and after surgery
Measured: 2 year
According to the 16s rDNA sequencing results, analyze the differences in intestinal flora of colon cancer patients with different TCM syndromes and TCM constitutions before and after surgery and their correlations
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start10 Mar 2019
- Primary completion1 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wei Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Xu, First Affiliated Hospital of Harbin Medical University
- Investigators
- Wei Xu, Professor, Principal investigator, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892252
- Sponsor's protocol ID
- V1.0
- Status last verified
- Sep 2021
- First submitted
- 14 Mar 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis of TCM Syndromes, TCM Constitution Types, Intestinal Microbial Evolution and Tumor Biological Characteristics in Colorectal Cancer Patients Before and After Surgery
- ClinicalTrials.gov ID
- NCT03892252
- Acronym / sponsor ID
- V1.0
- Conditions
- Colorectal Neoplasms
- Keywords
- gut microbiota, 16s rDNA sequebcing, TCM sydromes, TCM Constitution Types
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Wei XuUniversity, hospital or other
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 27 Mar 2019 (actual)
- 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.
Guided by the idea of combining disease differentiation with syndrome differentiation in traditional Chinese medicine, this study used the form of questionnaire to summarize the changes of TCM syndromes, TCM constitution types in colorectal cancer patients before and after surgery. The Next-generation sequencing technology was used to explore the changes and differences of intestinal microorganisms before and after surgery. The correlation between changes of TCM syndromes, TCM constitution types, intestinal microbial evolution and tumor biological characteristics in colorectal cancer patients before and after surgery was analyzed. To explore the rationality of TCM in the prevention and treatment of colorectal cancer recurrence and metastasis in order to guide the individualized treatment and dietary regulation of TCM.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| before surgery | – | Other: No interventionno intervention(s) |
| after surgery | – | Other: No interventionno intervention(s) |
| Normal colonoscopy | – | Other: No interventionPeople who were diagnosed by colonoscopy without colorectal cancer. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer patients admitted to the first affiliated hospital of Harbin medical university
Key inclusion criteria (5 listed)
- Preoperative abdominal CT, colonoscopy and pathological examination were diagnosed as colorectal malignant tumor patients;
- Having surgical indications;
- Patients who were not treated with antibiotics or microbiological agents one week before surgery;
- Patients who had not received radiotherapy and chemotherapy before surgery;
- Patients or their legal representatives informed and agreed to participate in this clinical trial and signed a written informed consent;
Key exclusion criteria (8 listed)
- Have other cancer history;
- Patients who have received invasive treatment within the past three months;
- Inflammatory bowel disease such as ulcerative colitis or crohn's disease;
- Combined with intestinal obstruction or intestinal perforation for emergency surgery;
- Psychiatric history, can not join and standardize the completion of clinical investigators;
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 interventionNo intervention | Other | Normal colonoscopy, after surgery, before surgery |
Primary outcome
According to the 16s rDNA sequencing results, characterize the intestinal microbiota characteristics of colon cancer patients with different TCM syndrome types and TCM constitutions before and after surgery
Time frame: 2 year
According to the 16s rDNA sequencing results, analyze the differences in intestinal flora of colon cancer patients with different TCM syndromes and TCM constitutions before and after surgery and their correlations
Time frame: 1 month
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 28 Sep 2021.
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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, Professor 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 Colorectal Neoplasms, run by Wei Xu 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 5 inclusion and 8 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 28 Sep 2021. 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?
According to the 16s rDNA sequencing results, characterize the intestinal microbiota characteristics of colon cancer patients with different TCM syndrome types and TCM constitutions before and after surgery (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2021.