MICROGAS: Characterisation of the Intratumoral Microbiome in Gastric Adenocarcinoma: to a Personalised Medicine

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Recruiting
CT.gov ID
NCT05800236
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other)
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Study Details

Study Description

Brief Summary

In this study, gastric tumours and adjacent healthy mucosa will be collected from gastric cancer patients operated on for curative purposes. From this material, presence and characterisation of intratumoral bacteria will be determined. Intratumoral microbiota composition will be compared with healthy adjacent tissue, and the intratumoral microbiota composition will also be compared between different tumor types. The different bacterial signatures that we will characterise may be used as biomarkers.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Gastrectomy
N/A

Detailed Description

Gastric adenocarcinoma is mainly linked to Helicobacter pylori infection, and this bacterium is classified as a class 1 carcinogen by the WHO. However, infection with this bacterium alone is not sufficient for the development of gastric adenocarcinoma. It is now recognised that environmental factors such as the digestive microbiota influence carcinogenesis. Improved sequencing techniques have shown that some tumours contain intracellular bacteria and that these are specific to the origin of the tumour. A study describing the existence of intratumoral bacteria was carried out on 7 different tumour types excluding gastric cancer. Gastric adenocarcinoma is a cancer with a poor prognosis, treatment, based mainly on surgery combined with conventional chemotherapy, is not very effective with a 5-year survival rate of less than 20%. Except for Her2+ cases, there is no specific treatment. It is therefore now essential to develop targeted and effective treatments.

The objective of this project is to define whether intratumoral bacteria exist in gastric cancer.

To achieve this, tumours and adjacent healthy mucosa from patients with gastric cancer will be collected and analysed in INSERM U1312 laboratory. The biological material studying consists only of remnants of biopsies of gastric tumours and adjacent healthy tissues, which are not needed in the pathology laboratory, from patients who undergo gastrectomy as part of their cancer management Two blood tubes for the isolation of possible circulating tumour cells will also be collected. From these materials, the presence of intratumoral bacteria will be determined by immunohistochemistry targeting components of the bacterial wall, by RNAscope® targeting 16S ribosomal RNA (16S rRNA) and by real-time quantitative PCR targeting 16S rDNA. Characterisation of the intratumoral microbiota will be performed by sequencing 16S rDNA gene. The collected blood will be tested for the presence of CSCs and, if CSCs are detected, the microbiota will be tested and characterised using the same techniques described above.

The primary endpoint will be the evidence of an intratumoral microbiota and its taxonomic description.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Characterisation of the Intratumoral Microbiome in Gastric Adenocarcinoma: to a Personalised Medicine
Anticipated Study Start Date :
Apr 22, 2023
Anticipated Primary Completion Date :
Mar 31, 2025
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Gastric adenocarcinoma

patients who undergo gastrectomy

Procedure: Gastrectomy
Patients operated on for curative purposes at the Bordeaux University Hospital for gastric adenocarcinoma of any type or stage and Collection of two venous blood tubes

Outcome Measures

Primary Outcome Measures

  1. Observation of type of intratumoral microbiota by microscopy [Day 1]

    Description of intratumoral microbiota in gastric adenocarcinoma, no statistical tests will be necessary.

Secondary Outcome Measures

  1. Detection of bacteria in CTCs [Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients operated on for curative purposes at the Bordeaux University Hospital for gastric adenocarcinoma of any type or stage

  • Histological evidence of gastric adenocarcinoma by biopsies taken at diagnosis

  • No oral opposition to participate after being informed about the study

  • Beneficiary of a social security scheme

  • Major

Exclusion Criteria:
  • Pregnant or breastfeeding woman

  • Patient placed under court protection

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital du Haut Lévêque Pessac France 33600

Sponsors and Collaborators

  • University Hospital, Bordeaux
  • Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Emilie BESSEDE, PharmD, PhD, University Hospital, Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT05800236
Other Study ID Numbers:
  • CHUBX 2022/09
First Posted:
Apr 5, 2023
Last Update Posted:
Apr 5, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2023