Colorectal NeoplasmsMETABIOTENCT03843905
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.
An observational study of Colorectal Neoplasms and Microbiota, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Microbiota, Prognosis
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2018to 15 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Histologically proven colonic or high rectal adenocarcinoma
Who may be able to join
- - 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
Who cannot join
- - < 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
Show all 9Show fewer
- Genetic CRC : familial adenomatous polyposis, hereditary non polyposis colorectal cancers (HNPCC).
- Patient requiring preoperative radio-chemotherapy or chemotherapy alone
- Medical history of cancer
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Lise LACLAUTRE, 0473754963, drci@chu-clermontferrand.fr
Julie VEZIANT
About this study
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.
Read the detailed description
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.
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).
- Conditions
- Colorectal Neoplasms, Microbiota, Prognosis, Metabolic Syndrome, Sarcopenia
- Being tested
- no intervention
- Keywords
- Gut microbiota, Colorectal cancer, Sarcopenia, Metabolic syndrome, Prognostic factors, Pathogenic E.coli
- Medical subject headings
- Colorectal Neoplasms, Metabolic Syndrome, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
defined by the time between surgery and last follow-up. The 5 years overall survival will be recorded.
Measured: at 5 years
Secondary outcomes (8)
Overall survival related to CRC
time between surgery and last follow-up. The1-3- and 5 years overall survivals will be recorded
Measured: 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
Measured: 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
Measured: at 30 days
length of hospital stay
length of hospital stay includes length of stay in Intensive Care unit and Conventional Hospital Unit.
Measured: at 3 months
postoperative mortality
postoperative death until 90 days after surgery
Measured: at 90 days
evolution of sarcopenia
evolution of skeletal muscle index (SMI) identified from pretreatment and oncology follow-up computed tomography scans
Measured: 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)
Measured: at 3,6,12 and 36 months
Microbiota composition
composition of the microbiota according to the sampling site (stools, Peritumoral mucosa and tumor)
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start15 Nov 2018
- Primary completion15 Nov 2018
- Study completion15 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- M2iSH laboratory, Benoit Chassaing
- Responsible party
- Sponsor
- Investigators
- Julie VEZIANT, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843905
- Sponsor's protocol ID
- CHU-424
- Other IDs
- 2018-A00352-53
- Acronym
- METABIOTE
- Status last verified
- Feb 2019
- First submitted
- 1 Feb 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31915159
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03843905
- Acronym / sponsor ID
- METABIOTE / CHU-424
- Conditions
- Colorectal Neoplasms, Microbiota, Prognosis, Metabolic Syndrome, Sarcopenia
- Keywords
- Gut microbiota, Colorectal cancer, Sarcopenia, Metabolic syndrome, Prognostic factors, Pathogenic E.coli
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- M2iSH laboratory, Benoit Chassaing
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2021 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Histologically proven colonic or high rectal adenocarcinoma
Key inclusion criteria (6 listed)
- - 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
Key exclusion criteria (9 listed)
- - < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionThe 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) | Other | – |
Primary outcome
Overall survival (OS)
Time frame: at 5 years
defined by the time between surgery and last follow-up. The 5 years overall survival will be recorded.
8 secondary outcomes
Overall survival related to CRC
Time frame: at 1, 3 and 5 years
Disease free survival (DFS)
Time frame: at 1, 3 and 5 years
post-operative morbidity
Time frame: at 30 days
length of hospital stay
Time frame: at 3 months
postoperative mortality
Time frame: at 90 days
evolution of sarcopenia
Time frame: at 3,6, 12 and 36 months
evolution Body Mass Index (BMI)
Time frame: at 3,6,12 and 36 months
Microbiota composition
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Derived from this study: PubMed 31915159Veziant 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.
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie VEZIANT principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Microbiota, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (0473754963, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: at 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03843905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.