Characterisation of the Intratumoral Microbiome in Gastric Adenocarcinoma: to a Personalised Medicine (MICROGAS)
Primary Purpose
Gastric Adenocarcinoma
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Gastrectomy
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Adenocarcinoma focused on measuring Gastric cancer, intratumoral microbiota, circulating tumour cells, biomarkers
Eligibility Criteria
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
Sites / Locations
- Hôpital du Haut LévêqueRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Gastric adenocarcinoma
Arm Description
patients who undergo gastrectomy
Outcomes
Primary Outcome Measures
Observation of type of intratumoral microbiota by microscopy
Description of intratumoral microbiota in gastric adenocarcinoma, no statistical tests will be necessary.
Secondary Outcome Measures
Detection of bacteria in CTCs
Full Information
NCT ID
NCT05800236
First Posted
March 23, 2023
Last Updated
March 23, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT05800236
Brief Title
Characterisation of the Intratumoral Microbiome in Gastric Adenocarcinoma: to a Personalised Medicine
Acronym
MICROGAS
Official Title
Characterisation of the Intratumoral Microbiome in Gastric Adenocarcinoma: to a Personalised Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2023 (Anticipated)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
Keywords
Gastric cancer, intratumoral microbiota, circulating tumour cells, biomarkers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gastric adenocarcinoma
Arm Type
Other
Arm Description
patients who undergo gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Gastrectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Observation of type of intratumoral microbiota by microscopy
Description
Description of intratumoral microbiota in gastric adenocarcinoma, no statistical tests will be necessary.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Detection of bacteria in CTCs
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie BESSEDE, PharmD, PhD
Phone
+335 56 79 56 67
Email
emilie.bessede@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marine JAUVAIN, PharmD
Phone
+335 56 79 56 67
Email
marine.jauvain@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie BESSEDE, PharmD, PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital du Haut Lévêque
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Gronnier, MD, PhD
Phone
+335 57 65 60 05
Email
caroline.gronnier@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Caroline Gronnier, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Characterisation of the Intratumoral Microbiome in Gastric Adenocarcinoma: to a Personalised Medicine
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