Clinical trial · Observational
Predictive Value of Innovative Prognostic Markers (Gut Microbiota, Sarcopenia, Metabolic Syndrome and Obesity) on Surgical and Oncologic Results in the Management of Sporadic Colorectal Adenocarcinoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Colorectal cancer (CRC), second leading cause of cancer worldwide, is associated with a poor prognosis, especially in patients with advanced disease. Therefore, there is still a need to develop new prognostic tools to replace or supplement those routinely used, with the aim to optimize treatment strategies. Studies on gut microbiota composition provide new strategies to identify powerful biomarkers. Indeed, beyond its beneficial functions for the host, increasing evidences suggest that gut microbiota is a key factor involved in CRC carcinogenesis. Many clinical studies have described an imbalance in the gut microbiota (dysbiosis) in CRC patients, with the emergence of pathogenic bacterial species, Recent studies reported that pks-positive E. coli, a pathogenic bacterial producing toxin encoded by the pks genomic island, is more frequently detected in CRC patients, suggesting a possible role in tumor development. Therefore, this suggests the potential use of microbial signatures associated with CRC for prognostic assessment. Furthermore, influence of body composition profile (BMI, sarcopenia, metabolic syndrome) also appears to be a new relevant prognostic tool regarding surgical and oncological outcomes following CRC surgery. The aim of this translational research project is to study the impact of these new prognostic tools on surgical and oncologic results in a prospective cohort of patients who underwent CRC surgery at the Digestive Surgery Department of the University Hospital of Clermont-Ferrand (France). This could allow to optimize treatment strategies and provide new ways to identify news promising biomarkers associations in order to better define high risk patients. Investigators aim to identify specific microbial signatures associated with some metabolic profiles in order to improve surgical morbidity and/or response to cancer therapies.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metabolic Syndrome | — | UNRESOLVED | — |
| Microbiota | — | UNRESOLVED | — |
| Prognosis | — | UNRESOLVED | — |
| Sarcopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- at 5 years
- description
- defined by the time between surgery and last follow-up. The 5 years overall survival will be recorded.
Secondary outcomes (8)
- measure
- Overall survival related to CRC
- timeFrame
- at 1, 3 and 5 years
- description
- time between surgery and last follow-up. The1-3- and 5 years overall survivals will be recorded
- measure
- Disease free survival (DFS)
- timeFrame
- at 1, 3 and 5 years
- description
- time between surgery and first identified recurrence. The1-3- and 5 years disease-free survivals will be recorded
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \- Male or female, age \> to 18 years. * Histologically proven colonic or high rectal adenocarcinoma * Absence of metastasis (CT scan) in exams performed preoperatively * No history of other tumors * Patients for whom the social and psychological status, the general condition are able to be monitored and/or compliant with the requirements of the study * Signed and dated informed consent document Exclusion Criteria: * \- \< 18 years, patient in legal incapacity (person deprived of liberty or under guardianship). * Antibiotic administration within the 2 months before surgery * Long-term probiotic oral intake * Inflammatory bowel disease (Crohn's disease, ulcerative colitis) * Preoperative bowel preparation (oral or rectal) inclued antibiotic and/or antiseptic preparation. * Metastatic disease * Genetic CRC : familial adenomatous polyposis, hereditary non polyposis colorectal cancers (HNPCC). * Patient requiring preoperative radio-chemotherapy or chemotherapy alone * Medical history of cancer
References
Publications (1)
- DERIVEDVeziant J, Poirot K, Chevarin C, Cassagnes L, Sauvanet P, Chassaing B, Robin F, Godfraind C, Barnich N, Pezet D, Pereira B, Gagniere J, Bonnet M. Prognostic value of a combination of innovative factors (gut microbiota, sarcopenia, obesity, metabolic syndrome) to predict surgical/oncologic outcomes following surgery for sporadic colorectal cancer: a prospective cohort study protocol (METABIOTE). BMJ Open. 2020 Jan 7;10(1):e031472. doi: 10.1136/bmjopen-2019-031472. PMID 31915159