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NCT03843905: METABIOTE

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.

Status unknown Last updated 18 February 2019
What this trial tests

trial testing no intervention in Colorectal Neoplasms in 300 participants. Status unknown.

Timeline
15 November 2018
Primary endpoint
15 November 2018
15 November 2021

Quick facts

Lead sponsorUniversity Hospital, Clermont-Ferrand
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment300
Start date15 November 2018
Primary completion15 November 2018
Estimated completion15 November 2021
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Clermont-Ferrand

Who can join

18 and older, any sex, with Colorectal Neoplasms or Microbiota. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Gut Microbiota as Potential Biomarker and/or Therapeutic Target to Improve the Management of Cancer: Focus on Colibactin-Producing <i>Escherichia coli</i> in Colorectal Cancer.
    Veziant J, Villéger R, Barnich N, Bonnet M. · · 2021 · cited 48× · PMID 34063108 · DOI 10.3390/cancers13092215
  2. 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).
    Veziant J, Poirot K, Chevarin C, Cassagnes L, et al · · 2020 · cited 11× · PMID 31915159 · DOI 10.1136/bmjopen-2019-031472
  3. Crosstalk between metabolic reprogramming and microbiota: implications for cancer progression and novel therapeutic opportunities.
    Li X, Jia Y, Li Y, Hei H, et al · · 2025 · cited 2× · PMID 40463381 · DOI 10.3389/fimmu.2025.1582166

Verify or expand the search:

Other trials of no intervention

Trials testing the same drug.

Other recruiting trials for Colorectal Neoplasms

Currently open trials in the same condition.

Other University Hospital, Clermont-Ferrand trials

Trials by the same sponsor.

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Data sources for this page

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