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Recruiting Observational

GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)

NCT05644431 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-07-19
Last updated
2023-08-30

Condition(s) studied

GastroEsophageal Cancer

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Describe Gastric and Gastroesophageal immunological tumor microenvironment — At least 36 months following inclusion
    Spatial, spectral cytometry, and transcriptomic analyses

Trial sites (1)

FacilityCityRegionStatus
Centre Léon Bérard Lyon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05644431 on ClinicalTrials.gov ↗ ← All trials in France