An observational study in Colorectal Neoplasms, Microbiota and Prognosis, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-18.
Sponsored by University Hospital, Clermont-Ferrand · Observational
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:
Following surgery will be collected :
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).
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's planned enrollment of 300 is above the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University Hospital, Clermont-Ferrand is the lead sponsor of 854 studies on the registry; 180 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Histologically proven colonic or high rectal adenocarcinoma
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
Overall survival (OS)
defined by the time between surgery and last follow-up. The 5 years overall survival will be recorded.
Time frame: at 5 years
Overall survival related to CRC
time between surgery and last follow-up. The1-3- and 5 years overall survivals will be recorded
Time frame: at 1, 3 and 5 years
Disease free survival (DFS)
time between surgery and first identified recurrence. The1-3- and 5 years disease-free survivals will be recorded
Time frame: at 1, 3 and 5 years
post-operative morbidity
incidence of postoperative complications (medical and surgical) according to the Clavien-Dindo classification occurring during the hospital stay and up-to 30-day after surgery will be recorded from the audit database
Time frame: at 30 days
length of hospital stay
length of hospital stay includes length of stay in Intensive Care unit and Conventional Hospital Unit.
Time frame: at 3 months
postoperative mortality
postoperative death until 90 days after surgery
Time frame: at 90 days
evolution of sarcopenia
evolution of skeletal muscle index (SMI) identified from pretreatment and oncology follow-up computed tomography scans
Time frame: at 3,6, 12 and 36 months
evolution Body Mass Index (BMI)
evolution Body Mass Index (BMI) defined during postoperative oncologic follow up clinical consultations (weight measurement)
Time frame: at 3,6,12 and 36 months
Microbiota composition
composition of the microbiota according to the sampling site (stools, Peritumoral mucosa and tumor)
Time frame: during surgery
Ran from Nov 2018 to primary completion in Nov 2018, 0 months.
Of 461 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 132. This study's 0 months is below that.
Counting every sponsor, half of 562 studies reached it within 53 months; a quarter within 28 and three quarters within 103.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Clermont-Ferrand →