Informations générales (source: ClinicalTrials.gov)
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. (METABIOTE)
Observational
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
novembre 2018
novembre 2021
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Chu Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Lise LACLAUTRE | Contact (sur clinicalTrials) | |||
Critères
Tous
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
-
- 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
-
- < 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