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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •- < 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
结局指标
主要结局
Overall survival (OS)
时间窗: at 5 years
defined by the time between surgery and last follow-up. The 5 years overall survival will be recorded.
次要结局
- Overall survival related to CRC(at 1, 3 and 5 years)
- Disease free survival (DFS)(at 1, 3 and 5 years)
- evolution Body Mass Index (BMI)(at 3,6,12 and 36 months)
- Microbiota composition(during surgery)
- post-operative morbidity(at 30 days)
- length of hospital stay(at 3 months)
- postoperative mortality(at 90 days)
- evolution of sarcopenia(at 3,6, 12 and 36 months)