Characterisation of the Intratumoral Microbiome in Gastric Adenocarcinoma: to a Personalised Medicine
MICROGAS
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2023
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedStudy Start
First participant enrolled
April 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedApril 5, 2023
March 1, 2023
1.9 years
March 23, 2023
March 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Observation of type of intratumoral microbiota by microscopy
Description of intratumoral microbiota in gastric adenocarcinoma, no statistical tests will be necessary.
Day 1
Secondary Outcomes (1)
Detection of bacteria in CTCs
Day 1
Study Arms (1)
Gastric adenocarcinoma
OTHERpatients who undergo gastrectomy
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or breastfeeding woman
- Patient placed under court protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital du Haut Lévêque
Pessac, 33600, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emilie BESSEDE, PharmD, PhD
University Hospital, Bordeaux
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2023
First Posted
April 5, 2023
Study Start
April 22, 2023
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
April 5, 2023
Record last verified: 2023-03