Last reviewed · How we verify
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.
trial testing no intervention in Colorectal Neoplasms in 300 participants. Status unknown.
15 November 2018
Quick facts
| Lead sponsor | University Hospital, Clermont-Ferrand |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 15 November 2018 |
| Primary completion | 15 November 2018 |
| Estimated completion | 15 November 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- no intervention
Conditions studied
- Colorectal Neoplasms — all drugs for Colorectal Neoplasms →
- Microbiota — all drugs for Microbiota →
- Prognosis — all drugs for Prognosis →
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
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):
-
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 -
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 -
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:
- PubMed search for NCT03843905
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03843905 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Clermont-Ferrand
- Last refreshed: 18 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03843905.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing