Metabolic Syndrome Clinical Trial
Official title:
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.
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.
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 and exclusion criteria. An oral and written information will be
given to patients, presenting the study.
Then, the following data will be collected propectively:
- Socio-demographic and medical data (personal and familial medical history, current
treatments, comorbidities, allergies, Body Mass Index (BMI), ASA score…)
- Blood tests results, including nutritional, hepatic assessment and exploration of a
lipidic abnormality.
- Body composition profile: Metabolic syndrome screening, BMI, waist circumference,
sarcopenia (skeletal muscle index calculation on CT scan).
- Thoraco-abdomino-pelvic CT scan: sarcopenia, hepatic and splenic density, thanks to a
dedicated software (Slice-O-Matic).
Following surgery will be collected :
- Pathological data (TNM stage, MSI, RAS and BRAF status…)
- Surgical results (30-day postoperative medical and surgical morbidity and 90-day
postoperative mortality)
- Oncologic results (Overall survival, Disease free survival…)
- Metabolic profile evolution: sarcopenia (SMI), BMI and waist circumference after 3, 6,
12 and 36 months, postoperatively.
Intraoperatively, samples of peritumoral mucosa and tumor specimen and rectal stools will be
frozen (-80°) and moved to the research unit for microbiota analysis. Interest bacteria will
be grown on selective gelosis and pathogenic E coli will be identified using PCR as well as
other specific bacteria involved in CRC. Moreover, global microbiota modifications will be
observed using high-throughput sequencing of the bacterial 16S rRNA gene. These data will be
associated with body composition profile, clinical data, surgical and oncologic results, and
pathological data thanks to a multivariate analysis.
The patients will be monitored according to the Digestive Oncology french recommendations
(TNCD).
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