NCT05800236

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

April 22, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 5, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

March 23, 2023

Last Update Submit

March 23, 2023

Conditions

Keywords

Gastric cancerintratumoral microbiotacirculating tumour cellsbiomarkers

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

OTHER

patients who undergo gastrectomy

Procedure: Gastrectomy

Interventions

GastrectomyPROCEDURE

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

Gastric adenocarcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Emilie BESSEDE, PharmD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie BESSEDE, PharmD, PhD

CONTACT

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

Locations