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Trial record 22 of 95 for:    body | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

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. (METABIOTE)

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ClinicalTrials.gov Identifier: NCT03843905
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
M2iSH laboratory
Benoit Chassaing
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment
Colorectal Neoplasms Microbiota Prognosis Metabolic Syndrome Sarcopenia Other: no intervention

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).


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : November 15, 2018
Estimated Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: no intervention
    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)


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival related to CRC [ Time Frame: at 1, 3 and 5 years ]
    time between surgery and last follow-up. The1-3- and 5 years overall survivals will be recorded

  2. Disease free survival (DFS) [ Time Frame: at 1, 3 and 5 years ]
    time between surgery and first identified recurrence. The1-3- and 5 years disease-free survivals will be recorded

  3. post-operative morbidity [ Time Frame: at 30 days ]
    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

  4. length of hospital stay [ Time Frame: at 3 months ]
    length of hospital stay includes length of stay in Intensive Care unit and Conventional Hospital Unit.

  5. postoperative mortality [ Time Frame: at 90 days ]
    postoperative death until 90 days after surgery

  6. evolution of sarcopenia [ Time Frame: at 3,6, 12 and 36 months ]
    evolution of skeletal muscle index (SMI) identified from pretreatment and oncology follow-up computed tomography scans

  7. evolution Body Mass Index (BMI) [ Time Frame: at 3,6,12 and 36 months ]
    evolution Body Mass Index (BMI) defined during postoperative oncologic follow up clinical consultations (weight measurement)

  8. Microbiota composition [ Time Frame: during surgery ]
    composition of the microbiota according to the sampling site (stools, Peritumoral mucosa and tumor)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Histologically proven colonic or high rectal adenocarcinoma
Criteria

Inclusion Criteria:

  • - 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

Exclusion Criteria:

  • - < 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843905


Contacts
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Contact: Lise LACLAUTRE 0473754963 drci@chu-clermontferrand.fr

Locations
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France
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    0473754963    drci@chu-clermontferrand.fr   
Principal Investigator: Julie VEZIANT         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
M2iSH laboratory
Benoit Chassaing
Investigators
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Principal Investigator: Julie VEZIANT University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03843905     History of Changes
Other Study ID Numbers: CHU-424
2018-A00352-53 ( Other Identifier: 2018-A00352-53 )
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Gut microbiota
Colorectal cancer
Sarcopenia
Metabolic syndrome
Prognostic factors
Pathogenic E.coli

Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Adenocarcinoma
Sarcopenia
Colorectal Neoplasms
Disease
Pathologic Processes
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases