Gut MicrobiotaNCT03383159
Gut Microbiota Prediction of Metachronous Colorectal Neoplasms
An observational study of Gut Microbiota and Metachronous Adenoma, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
Patients with colorectal cancer are known to be at high risk of developing metachronous adenoma, however, participation in colonoscopy are low. Colonoscopy, the primary modality used all over the word, is costly and invasive, and its efficacy depends on the endoscopist's skill and the patient's bowel preparation. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Gut Microbiota, Metachronous Adenoma
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2016to 30 Sep 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients underwent an exhaustive colorectal cancer surgical resection in the First Affiliated Hospital of Harbin Medical University from December 1, 2012 to April 28, 2017. Each participant provided a fresh stool sample in hospital before bowel preparation or 1 month after colonoscopy. All patients did not use antibiotics and probiotics 3 mouth before samples collection.
Who may be able to join
- Requirements of informed consent and assent of participant, parent or legal guardian as applicable
- Patients who underwent exhaustive colorectal cancer surgical resection and accept colonoscopy
- Patients between the age of 35 and 75 years old without considering sex
- Patients with BMI= 18.5-23.9
- Participants can follow the visit plan
Who cannot join
- Patients with colorectal cancer with distant metastasis
- Chronic renal diseases and hepatic cirrhosis
- Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months
- Individuals with a history of Chronic diarrhea
- Individuals with a history of Diabetes mellitus
- Individuals with a history of Hypertension
Show all 11Show fewer
- Individuals with a history of autoimmune diseases
- Use of antibiotics and probiotics 3 mouth before samples collection
- Individuals with a history of abdominal operation due to any reason
- Individuals with any history of cancer other than colorectal cancer
- Individuals with Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001
Yunwei Wei, +86-0451-85553099, hydwyw11@hotmail.com
About this study
Official title: Gut Microbiota Prediction of Metachronous Colorectal Neoplasms in Patients With Colorectal Cancer
Patients with colorectal cancer are known to be at high risk of developing metachronous adenoma, however, participation in colonoscopy are low. Colonoscopy, the primary modality used all over the word, is costly and invasive, and its efficacy depends on the endoscopist's skill and the patient's bowel preparation. As life expectancy of patients with history of colon cancer is increasing, colonoscopy would increase the overall cost for patients and for the health care system. This study aim to construct a predictive model of postoperative colorectal neoplasm development using microbiota analysis.
Read the detailed description
Colorectal cancer(CRC) is one of the most common malignancies in China and in Western countries. Furthermore, those with a history of CRC are at a higher risk for developing metachronous adenomas or CRC recurrence during the followup period. It has been reported that 0.7% of patients develop metachronous CRC during the 3 years after surgical resection for the initial CRC.
Surveillance colonoscopy is highly recommended by major international scientific societies with the intent of either detecting anastomotic recurrence at an early, curable stage or identifying metachronous premalignant(ie, adenomas) and malignant lesions. As life expectancy of patients with history of colon cancer is increasing, the costly and invasive postoperative examination increased the overall cost and suffering for patients.
The human colon plays host to a diverse and metabolically complex community of microorganisms. While colonic microbiome development along the colorectal adenoma-carcinoma sequence. Investigators speculate that gut microbiota related to metachronous adenoma or CRC, after curative treatment.
This study aim to discover if any difference of gut microbiota exist in patients who suffer from metachronous adenomas compared with patients who do not. Further try to seek the divergence microbiota of metachronous adenomas between Proximal and Distal Colorectum. construct a predictive model of postoperative colorectal neoplasm development using microbiota analysis. Finally, using microbita construct a predictive model of postoperative colorectal neoplasm development.
- Conditions
- Gut Microbiota, Metachronous Adenoma
- Keywords
- Microbiota, Metachronous Adenoma, Colorectal Cancer, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation group 1 | Patients who suffered metachronous adenoma after proximal colorectum cancer surgery. | |
| Control group 1 | Patients who do not suffere metachronous adenoma after proximal colorectum cancer surgery. | |
| Observation group 2 | Patients who suffered metachronous adenoma after distal colorectum cancer surgery. | |
| Control group 2 | Patients who do not suffered metachronous adenoma after distal colorectum cancer surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences In Microbiota
The diversity, structure of microbiota and relative abundance of special bacterial taxa 16S rRNA gene sequencing will be performed.
Measured: 1, 3 and 5 years after surgery
Secondary outcomes (2)
Predictive model establish
Using microbita construct a predictive model of postoperative colorectal neoplasm development.
Measured: June to August of 2018
Predictive model validation
Validation the accuracy of the predictive model.
Measured: August of 2018 to April of 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 May 2016
- Primary completion30 May 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunwei Wei, Principal investigator, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383159
- Sponsor's protocol ID
- Yunwei Wei 2017-3
- Status last verified
- Oct 2017
- First submitted
- 17 Dec 2017
- Last updated
- 27 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota Prediction of Metachronous Colorectal Neoplasms in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03383159
- Acronym / sponsor ID
- Yunwei Wei 2017-3
- Conditions
- Gut Microbiota, Metachronous Adenoma
- Keywords
- Microbiota, Metachronous Adenoma, Colorectal Cancer, Colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 26 Dec 2017 (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.
Patients with colorectal cancer are known to be at high risk of developing metachronous adenoma, however, participation in colonoscopy are low. Colonoscopy, the primary modality used all over the word, is costly and invasive, and its efficacy depends on the endoscopist's skill and the patient's bowel preparation. As life expectancy of patients with history of colon cancer is increasing, colonoscopy would increase the overall cost for patients and for the health care system. This study aim to construct a predictive model of postoperative colorectal neoplasm development using microbiota analysis.
Detailed description
Colorectal cancer(CRC) is one of the most common malignancies in China and in Western countries. Furthermore, those with a history of CRC are at a higher risk for developing metachronous adenomas or CRC recurrence during the followup period. It has been reported that 0.7% of patients develop metachronous CRC during the 3 years after surgical resection for the initial CRC.
Surveillance colonoscopy is highly recommended by major international scientific societies with the intent of either detecting anastomotic recurrence at an early, curable stage or identifying metachronous premalignant(ie, adenomas) and malignant lesions. As life expectancy of patients with history of colon cancer is increasing, the costly and invasive postoperative examination increased the overall cost and suffering for patients.
The human colon plays host to a diverse and metabolically complex community of microorganisms. While colonic microbiome development along the colorectal adenoma-carcinoma sequence. Investigators speculate that gut microbiota related to metachronous adenoma or CRC, after curative treatment.
This study aim to discover if any difference of gut microbiota exist in patients who suffer from metachronous adenomas compared with patients who do not. Further try to seek the divergence microbiota of metachronous adenomas between Proximal and Distal Colorectum. construct a predictive model of postoperative colorectal neoplasm development using microbiota analysis. Finally, using microbita construct a predictive model of postoperative colorectal neoplasm development.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Observation group 1 | – | –Patients who suffered metachronous adenoma after proximal colorectum cancer surgery. |
| Control group 1 | – | –Patients who do not suffere metachronous adenoma after proximal colorectum cancer surgery. |
| Observation group 2 | – | –Patients who suffered metachronous adenoma after distal colorectum cancer surgery. |
| Control group 2 | – | –Patients who do not suffered metachronous adenoma after distal colorectum cancer surgery. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients underwent an exhaustive colorectal cancer surgical resection in the First Affiliated Hospital of Harbin Medical University from December 1, 2012 to April 28, 2017. Each participant provided a fresh stool sample in hospital before bowel preparation or 1 month after colonoscopy. All patients did not use antibiotics and probiotics 3 mouth before samples collection.
Key inclusion criteria (5 listed)
- Requirements of informed consent and assent of participant, parent or legal guardian as applicable
- Patients who underwent exhaustive colorectal cancer surgical resection and accept colonoscopy
- Patients between the age of 35 and 75 years old without considering sex
- Patients with BMI= 18.5-23.9
- Participants can follow the visit plan
Key exclusion criteria (11 listed)
- Patients with colorectal cancer with distant metastasis
- Chronic renal diseases and hepatic cirrhosis
- Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months
- Individuals with a history of Chronic diarrhea
- Individuals with a history of Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences In Microbiota
Time frame: 1, 3 and 5 years after surgery
The diversity, structure of microbiota and relative abundance of special bacterial taxa 16S rRNA gene sequencing will be performed.
2 secondary outcomes
Predictive model establish
Time frame: June to August of 2018
Predictive model validation
Time frame: August of 2018 to April of 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Gut Microbiota
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
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.
Yunwei Wei 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 Gut Microbiota and Metachronous Adenoma, 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunwei Wei (+86045185553099, hydwyw11@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences In Microbiota (time frame: 1, 3 and 5 years after surgery). 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 27 Jun 2018.