Characterisation of the Intratumoral Microbiome in Gastric Adenocarcinoma: to a Personalised Medicine (MICROGAS)
Study Overview
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emilie BESSEDE, PharmD, PhD
- Phone Number: +335 56 79 56 67
- Email: emilie.bessede@chu-bordeaux.fr
Study Contact Backup
- Name: Marine JAUVAIN, PharmD
- Phone Number: +335 56 79 56 67
- Email: marine.jauvain@chu-bordeaux.fr
Study Locations
-
-
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Pessac, France, 33600
- Recruiting
- Hôpital du Haut Lévêque
-
Contact:
- Caroline Gronnier, MD, PhD
- Phone Number: +335 57 65 60 05
- Email: caroline.gronnier@chu-bordeaux.fr
-
Principal Investigator:
- Caroline GRONNIER, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Sponsor
Investigators
- Principal Investigator: Emilie BESSEDE, PharmD, PhD, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
Studies a U.S. FDA-regulated device product
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