Investigating the Gut Microbiota of Individuals With Adenoma, Advanced Adenoma and Colorectal Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
Colorectal cancer (CRC) is one of the most common malignancies worldwide. CRC is now the commonest cancer and the second cause of cancer death in Hong Kong. Most CRCs begin as small polyps. Some polyps in particular adenomas may gradually develop into cancer. Early detection of cancer can facilitate successful treatment, and early detection of adenomas can prevent and decrease CRC incidence. Therefore, many efforts are being made to screening of colorectal adenoma and cancer, which will benefit public health greatly in Hong Kong and worldwide.
Abnormality in the composition of the gut microbiota has been implicated as a potentially important etiological factor in the initiation and progression of CRC. With the widespread application of metagenomic analyses in the investigation of intestinal microbiota, an increasing number of bacteria have been identified to be positively associated with CRC. Recent basic research has established a critical function for the intestinal microbiota and specific bacterial species, in promoting colorectal tumorigenesis.
Based on the previously identified microbial markers, the investigators have recently proven that fecal microbial markers can also serve in non-invasive diagnosis of recurrent adenoma in post polypectomy patients. The results have shown that, the panel of microbial markers composing of Fusobacterium nucleatum (Fn), Bacteroides clarus (Bc), Clostridium hathewayi (Ch), and the Lachnoclostridium marker m3 shows good diagnostic performance for colorectal adenoma and CRC. Microbial markers can be used to predict risk of adenoma recurrence during follow-up surveillance, with different scoring algorithms and cutoff values as compared to those used for colorectal neoplasm screening. However, only retrospective samples were used in the previous study, and sample size was limited. A prospective study is warranted to verify the accuracy of the microbial test for predicting recurrent adenoma.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- Prince of Wales Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- History of polypectomy or surgical removal of adenoma or CRC within the past 10 years
- Will undergo a scheduled standard colonoscopy examination
Exclusion Criteria:
- History of inflammatory bowel disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
N
Healthy control
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This diagnosis test is commonly used for screening CRC, which can act as an indicator to compare the performance of our new molecular test
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nAA
Subject diagnosed with non-advanced adenoma
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This diagnosis test is commonly used for screening CRC, which can act as an indicator to compare the performance of our new molecular test
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AA
Subject diagnosed with advanced adenoma
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This diagnosis test is commonly used for screening CRC, which can act as an indicator to compare the performance of our new molecular test
|
|
CRC
Subject diagnosed with colorectal cancer
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This diagnosis test is commonly used for screening CRC, which can act as an indicator to compare the performance of our new molecular test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Determine the performance of microbial markers in predicting adenoma and CRC
Time Frame: 3 months after stool sample submission
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3 months after stool sample submission
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Compare microbiome composition between healthy subjects and populations with adenoma, advanced adenoma, and colorectal cancer
Time Frame: Approximately 1 year after completed subject recruitment of the study
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Approximately 1 year after completed subject recruitment of the study
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Delineate the gut microbial community profiles of the population with adenoma, advanced adenoma, and colorectal cancer residing in different geographical locations with different lifestyles
Time Frame: Approximately 1 year after completed subject recruitment of the study
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Approximately 1 year after completed subject recruitment of the study
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- CREC 2021.036
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
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