Colorectal Cancer Clinical Trial
Official title:
Fecal Metagenomics and Metabolomics Analyses to Identify Potential Screening Biomarkers for Colorectal Polyps and Cancer in Chinese Population
NCT number | NCT04947930 |
Other study ID # | 2021SYSUMMS |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2021 |
Est. completion date | July 2023 |
Many previous studies had revealed that gastrointestinal microbiome is changed compositionally and ecologically in patients with colorectal cancer comparing with healthy population. These finding provide us with a new sight to take advantage of gut microbiota. The current study aims to explore new potential biomarkers for early screening and prognostic prediction of colorectal cancer and colorectal polyps by analyzing metagenomics and metabolomics of gut microbiota.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | July 2023 |
Est. primary completion date | July 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Participants aged 18 to 80 years old. 2. Participants who had been diagnosed with colorectal cancer or advanced colorectal polyps for the first time according to pathology results. 3. Participants who had signed informed consent. 4. Participants must have the ability to complete the questionnaires of the study. Exclusion Criteria: 1. Participants who had a positive personal history of colorectal polyps. 2. Participants who had a positive personal history of colorectal cancer. 3. Participants who had a positive personal history of other gastrointestinal diseases, such as inflammatory bowel disease, intestinal tuberculosis, or irritable bowel syndrome. 4. Participants who had undergone a colonoscopy or other procedure requiring bowel preparation in the last two months. 5. Participants who had been hospitalized for any reason in the last two months. 6. Participants who had consumed antibiotics for any reason in the last three months. 7. Participants who had consumed prebiotic supplements regularly in the last year. 8. 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. |
Country | Name | City | State |
---|---|---|---|
China | The Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sixth Affiliated Hospital, Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and specificity of the screening tool generated from fecal metagenomics and metabolomics data. | 12months |
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