Actively Recruiting
GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)
Led by Centre Leon Berard · Updated on 2023-08-30
50
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a prospective, monocentric, non-therapeutic, interventional cohort study aiming to decipher the immune TME through standard neoadjuvant CT in resectable G/GEJ adenocarcinomas. This study will also longitudinally monitor MRD during neoadjuvant and adjuvant therapy.
CONDITIONS
Official Title
GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient > 18 years of age on day of signing informed consent.
- Histologically proven non-metastatic resectable gastric and gastroesophageal junction adenocarcinoma, Stage IB to III to be treated with standard neoadjuvant treatment.
- Surgery of primary tumor to be done at Centre Léon Bérard.
- Availability of archival FFPE tumor block from initial diagnosis with at least 20% of tumor cells.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
- Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
- Patients must be covered by a medical insurance.
You will not qualify if you...
- Any condition contraindicated with blood sampling procedures required by the protocol.
- Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
- Pregnant or breast-feeding woman.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre Léon Bérard
Lyon, France, 69000
Actively Recruiting
Research Team
C
Clélia COUTZAC, MD
CONTACT
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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