Status:
UNKNOWN
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.
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
M2iSH laboratory
Benoit Chassaing
Conditions:
Colorectal Neoplasms
Microbiota
Eligibility:
All Genders
18+ years
Brief Summary
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 pr...
Detailed Description
The METABIOTE study will be systematically proposed to patients selected for sporadic CRC surgery during the first preoperative outpatient visit. The attending surgeon will double-check all inclusion ...
Eligibility Criteria
Inclusion
- \- 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
- \- \< 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
Key Trial Info
Start Date :
November 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 15 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03843905
Start Date
November 15 2018
End Date
November 15 2021
Last Update
February 18 2019
Active Locations (1)
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1
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003