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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)

15. februar 2019 oppdatert av: University Hospital, Clermont-Ferrand

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Observasjonsmessig

Registrering (Forventet)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Clermont-Ferrand, Frankrike, 63003
        • Rekruttering
        • CHU Clermont-Ferrand
        • Ta kontakt med:
        • Hovedetterforsker:
          • Julie VEZIANT

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with Histologically proven colonic or high rectal adenocarcinoma

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall survival (OS)
Tidsramme: at 5 years
defined by the time between surgery and last follow-up. The 5 years overall survival will be recorded.
at 5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall survival related to CRC
Tidsramme: at 1, 3 and 5 years
time between surgery and last follow-up. The1-3- and 5 years overall survivals will be recorded
at 1, 3 and 5 years
Disease free survival (DFS)
Tidsramme: at 1, 3 and 5 years
time between surgery and first identified recurrence. The1-3- and 5 years disease-free survivals will be recorded
at 1, 3 and 5 years
post-operative morbidity
Tidsramme: 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
at 30 days
length of hospital stay
Tidsramme: at 3 months
length of hospital stay includes length of stay in Intensive Care unit and Conventional Hospital Unit.
at 3 months
postoperative mortality
Tidsramme: at 90 days
postoperative death until 90 days after surgery
at 90 days
evolution of sarcopenia
Tidsramme: at 3,6, 12 and 36 months
evolution of skeletal muscle index (SMI) identified from pretreatment and oncology follow-up computed tomography scans
at 3,6, 12 and 36 months
evolution Body Mass Index (BMI)
Tidsramme: at 3,6,12 and 36 months
evolution Body Mass Index (BMI) defined during postoperative oncologic follow up clinical consultations (weight measurement)
at 3,6,12 and 36 months
Microbiota composition
Tidsramme: during surgery
composition of the microbiota according to the sampling site (stools, Peritumoral mucosa and tumor)
during surgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Clermont-Ferrand

Samarbeidspartnere

M2iSH laboratory
Benoit Chassaing

Etterforskere

  • Hovedetterforsker: Julie VEZIANT, University Hospital, Clermont-Ferrand

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. november 2018

Primær fullføring (Faktiske)

15. november 2018

Studiet fullført (Forventet)

15. november 2021

Datoer for studieregistrering

Først innsendt

1. februar 2019

Først innsendt som oppfylte QC-kriteriene

15. februar 2019

Først lagt ut (Faktiske)

18. februar 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. februar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. februar 2019

Sist bekreftet

1. februar 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CHU-424
  • 2018-A00352-53 (Annen identifikator: 2018-A00352-53)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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