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

March 23, 2023 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Pessac, France, 33600
        • Recruiting
        • Hopital du haut Leveque
        • Contact:
        • Principal Investigator:
          • Caroline GRONNIER, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observation of type of intratumoral microbiota by microscopy
Time Frame: Day 1
Description of intratumoral microbiota in gastric adenocarcinoma, no statistical tests will be necessary.
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Detection of bacteria in CTCs
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 22, 2023

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2022/09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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