GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: GastroEsophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Clinicobiological Cohort Study Aiming to Decipher Tumor Immune Microenvironment Evolution Under Standard Chemotherapy in Localized and Resectable Gastric and Gastroesophageal Junctional Adenocarcinomas
Overview
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.
Primary outcome measures
- Describe Gastric and Gastroesophageal immunological tumor microenvironment [Time frame: At least 36 months following inclusion]
Secondary outcome measures (5)
- Understand the evolution of the immune tumor microenvironment and its spatial structuration through standard neoadjuvant chemotherapy. [Time frame: At least 36 months following inclusion]
- Characterize the evolution of the immune tumor environment profiles and organization between responder and non-responder patients under standard neoadjuvant treatment. [Time frame: At least 36 months following inclusion]
- Characterize the immune profile in lymph nodes after surgery (lymphadenectomy) between responder and non-responder patients to neoadjuvant under standard neoadjuvant treatment. [Time frame: At least 36 months following inclusion]
- Assess the phenotype and functions of circulating immunes cells [Time frame: At least 36 months following inclusion]
- Perform integrative analysis combining spatial, molecular, single cell RNAseq, and spectral flow cytometry analysis on the immunological tumor environment in matched tumor tissues longitudinally [Time frame: At least 36 months following inclusion]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Centre Léon Bérard — Lyon
Identifiers
NCT: NCT05644431 · ET22-201