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Trial Title:
Characterisation of the Intratumoral Microbiome in Gastric Adenocarcinoma: to a Personalised Medicine
NCT ID:
NCT05800236
Condition:
Gastric Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Conditions: Keywords:
Gastric cancer
intratumoral microbiota
circulating tumour cells
biomarkers
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Gastrectomy
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
Arm group label:
Gastric adenocarcinoma
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital du Haut Lévêque
Address:
City:
Pessac
Zip:
33600
Country:
France
Status:
Recruiting
Contact:
Last name:
Caroline Gronnier, MD, PhD
Phone:
+335 57 65 60 05
Email:
caroline.gronnier@chu-bordeaux.fr
Investigator:
Last name:
Caroline Gronnier, MD, PhD
Email:
Principal Investigator
Start date:
April 22, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
University Hospital, Bordeaux
Agency class:
Other
Collaborator:
Agency:
Institut National de la Santé Et de la Recherche Médicale, France
Agency class:
Other
Source:
University Hospital, Bordeaux
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05800236
