Microbiome-based Diagnostic Tool for the Screening of Colorectal Cancer (GUILTI)
Colorectal cancer (CRC) is one of the most common cancer and cause of cancer death worldwide. Population-based screening programs for average risk populations have proven effective in reducing both incidence and mortality of CRC through early detection of cancer. The fecal immunochemical testing (FIT), has still a subo
| Condition(s) | Colorectal Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Colorectal cancer (CRC) is one of the most common cancer and cause of cancer death worldwide. Population-based screening programs for average risk populations have proven effective in reducing both incidence and mortality of CRC through early detection of cancer. The fecal immunochemical testing (FIT), has still a suboptimal diagnostic yield, with both missed adenomas and, mainly, unnecessary colonoscopies.The identification of novel, non-invasive biomarkers is currently one of the research areas driving most expenditure forces in the field of CRC.A large body of evidence shows that alterations of the gut microbiome and the enrichment of specific taxa(e.g. Fusobacterium nucleatum, Parvimonas micra, and others) are involved in the pathogenesis of CRC. Moreover, recent studies, have discover |
| Who can participate | Inclusion Criteria: * Patients participating in the national CRC screening program (50-74 years old) * Positivity to the FIT; * Ability to provide written informed consent and to be compliant with the study procedures. Exclusion Criteria: * Patients unfit for colonoscopy; * Other oncological conditions; * Concomitant severe comorbidities or gastrointestinal (GI) organic diseases (e.g. diverticular disease, inflammatory bowel disease); * Antibiotics, proton pump inhibitors or probiotics within 4 weeks prior to enrollment. |
| Ages | 50 Years to 74 Years |
| Sex | All |
| Lead sponsor | Catholic University of the Sacred Heart |
| Locations | Rome, RM, Italy |
| Start date | 2025-02-07 |
| NCT ID | NCT06738173 |
| Official listing | https://clinicaltrials.gov/study/NCT06738173 |