- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03667495
The Relationship Between Postoperative Changes of Oral and Intestinal Flora and Prognosis
Postoperative Oral and Intestinal Flora Changes in Patients With Colorectal Cancer and the Relationship Between These Changes and Prognosis
Study Overview
Status
Conditions
Detailed Description
Colorectal cancer is a major cause of cancerrelated deaths and the third most commonly diagnosed cancer worldwide.Current estimates indicate that 20-30% of those who undergo treatment will experience recurrence and 35% of all patients will die within 5 years.
The human colon plays host to a diverse and metabolically complex community of microorganisms. While the specific oral microbiome has been found to contribute to the development of colorectal cancer. Investigators speculate that specific oral microbiota related to colorectal cancer relapse after curative treatment.
Patients are routinely offered surveillance in order to detect disease recurrence at an early, asymptomatic stage, with the intention of improving survival. Nevertheless, controversy continues to surround the optimal surveillance protocols. Investigators aim to discover if any difference of oral microbiota is exist in patients who suffer from relapse compared with patients who do not.
Future surveillance after colorectal cancer treatment should focus on risk-stratification. Finally investigators will develop patient-centred programmes of surveillance protocols base on microbiota analysis.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Rui Geng
- Phone Number: +8613263695371
- Email: gengruihyd@163.com
Study Locations
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Heilongjiang
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Harbin, Heilongjiang, China, 150001
- Recruiting
- Yunwei Wei
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Contact:
- Yunwei Wei
- Email: hydwyw11@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Remission
Patients who get remission after curative surgery
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Relapse
Patients who suffered colorectal cancer or adenoma relapse after curative surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Colorectal cancer or adenoma recurred
Time Frame: 12 months after surgery
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Use colonoscopy to check for recurrence of colorectal cancer
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12 months after surgery
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Collaborators and Investigators
Investigators
- Study Director: Yunwei Wei, First Affiliated Hospital of Harbin Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Yunwei Wei 2018-09-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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