Actively Recruiting
A Prospective Clinicobiological Cohort Study to Understand Tumor Immune Microenvironment Changes During Standard Chemotherapy in Localized and Resectable Gastric and Gastroesophageal Junction Adenocarcinomas
Led by Centre Leon Berard · Updated on 2023-08-30
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the immune tumor microenvironment in patients with localized and resectable gastric and gastroesophageal junction adenocarcinomas undergoing standard neoadjuvant chemotherapy. The study is a prospective, monocentric, interventional cohort trial aiming to understand immune changes and minimal residual disease during treatment both before and after surgery. Participants receive standard chemotherapy as part of their usual care for localized gastric or gastroesophageal junction cancers. The study monitors the immune environment of tumors and lymph nodes through tissue samples collected before treatment, during surgery, and after chemotherapy. The research involves detailed molecular and cellular analyses to track immune cell behavior over time. During the study, participants will have tissue and blood samples collected for immune profiling, including advanced molecular techniques like single-cell RNA sequencing and flow cytometry. Outcomes include describing the immune tumor microenvironment and its evolution over at least 36 months post-inclusion. Patients are closely monitored during their standard treatment, with the study aiming to reveal immune factors influencing response to therapy.
CONDITIONS
Brief Title
GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient over 18 years old at the time of signing informed consent
- Histologically confirmed non-metastatic, resectable gastric or gastroesophageal junction adenocarcinoma, Stage IB to III
- Planned surgery of the primary tumor at Centre Léon Bérard
- Availability of archival tumor tissue with at least 20% tumor cells
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Ability to understand and sign informed consent and comply with study procedures
- Medical insurance coverage
You will not qualify if you...
- Any condition that prevents required blood sampling procedures
- Active additional cancers needing treatment, except for treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer
- Psychological, social, or geographic situations preventing informed consent or study compliance
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 36 months following inclusion
Participants who undergo standard chemotherapy in localized and resectable gastric and gastroesophageal junction adenocarcinomas are observed to understand changes in the tumor immune microenvironment.
Periodic visits as per standard chemotherapy and follow-up schedules
Trial Site Locations
Total: 1 location
1
Centre Léon Bérard
Lyon, France, 69000
Actively Recruiting
Research Team
C
Clélia COUTZAC, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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