- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04947930
Fecal Metagenomics and Metabolomics Analyses to Identify Potential Screening Biomarkers for Colorectal Polyps and Cancer in Chinese Population
Study Overview
Status
Detailed Description
Patients who come to the Sixth Affiliated Hospital, Sun Yat-sen University for medical purposes will be invited to participate in the study. Participants will be asked to collect two stool samples. One stool sample will be used for metagenomic sequencing and the other will be used to extract metabolomics data. Meanwhile, participants will be asked to complete a questionnaire about lifestyle and diet habits with the assistance of a well-trained nurse.
We will delineate the community and metabolites differences in the gut microbiota between colorectal cancer patients and healthy populations by comparing cases with controls. Considering the different gut microbiota profiles among different populations caused by varied diet habits and lifestyles, the current study will try to describe the microbiota profiles in the Chinese population. Besides, we will explore new potential biomarkers for early screening and prognostic prediction which is suitable to Chinese populations. Moreover, we will attempt to find out the interactions between diet and microbiota through a comprehensive analysis of the questionnaire and the collected results.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ping Lan, MD
- Phone Number: +86-13710316769
- Email: lanping@mail.sysu.edu.cn
Study Contact Backup
- Name: Xiaosheng He, PhD
- Phone Number: +86-13543490940
- Email: hexsheng@mail.sysu.edu.cn
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510655
- the Sixth Affiliated Hospital, Sun Yat-sen University
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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:
- Participants aged 18 to 80 years old.
- Participants who had been diagnosed with colorectal cancer or advanced colorectal polyps for the first time according to pathology results.
- Participants who had signed informed consent.
- Participants must have the ability to complete the questionnaires of the study.
Exclusion Criteria:
- Participants who had a positive personal history of colorectal polyps.
- Participants who had a positive personal history of colorectal cancer.
- Participants who had a positive personal history of other gastrointestinal diseases, such as inflammatory bowel disease, intestinal tuberculosis, or irritable bowel syndrome.
- Participants who had undergone a colonoscopy or other procedure requiring bowel preparation in the last two months.
- Participants who had been hospitalized for any reason in the last two months.
- Participants who had consumed antibiotics for any reason in the last three months.
- Participants who had consumed prebiotic supplements regularly in the last year.
- Participants who had other physical conditions that didn't suitable to participate in the study, such as severe cardiovascular diseases, serious mental illness, or pregnant status.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity and specificity of the screening tool generated from fecal metagenomics and metabolomics data.
Time Frame: 12months
|
12months
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Collaborators and Investigators
Investigators
- Principal Investigator: Ping Lan, MD, the Sixth Affiliated Hospital, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021SYSUMMS
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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