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.

NCT03843905 | Unknown

• 2 other identifiers: CHU-4242018-A00352-53
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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 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

Colorectal Neoplasms; Microbiota; Prognosis; Metabolic Syndrome; Sarcopenia

Keywords

Gut microbiota; Colorectal cancer; Sarcopenia; Metabolic syndrome; Prognostic factors; Pathogenic E.coli

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  defined by the time between surgery and last follow-up. The 5 years overall survival will be recorded.

  at 5 years

Secondary Outcomes (8)

• Overall survival related to CRC

  at 1, 3 and 5 years

• Disease free survival (DFS)

  at 1, 3 and 5 years

• post-operative morbidity

  at 30 days

• length of hospital stay

  at 3 months

• postoperative mortality

  at 90 days

Interventions

no intervention OTHER

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Histologically proven colonic or high rectal adenocarcinoma

You may qualify if:

• \- 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

You may not qualify if:

• \- \< 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• M2iSH laboratory: collaborator
• Benoit Chassaing: collaborator

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

• Veziant 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 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Metabolic Syndrome; Sarcopenia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Julie VEZIANT

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

0473754963; drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 18, 2019
• Study Start: November 15, 2018
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2021
• Last Updated: February 18, 2019

Record last verified: 2019-02

Locations

FR (1)