GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)

Last updated: August 29, 2023
Sponsor: Centre Leon Berard
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05644431
ET22-201
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Male or female patient > 18 years of age on day of signing informed consent.
  • Histologically proven non-metastatic resectable gastric and gastroesophageal junctionadenocarcinoma, 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% oftumor cells.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
  • Patient should understand, sign, and date the written voluntary informed consent format the screening visit prior to any protocol-specific procedures performed. Patientshould be able and willing to comply with study visits and procedures as per protocol.
  • Patients must be covered by a medical insurance.

Exclusion

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 cellcarcinoma of the skin, or in situ cervical cancer
  • Any psychological, familial, geographic or social situation, according to the judgmentof investigator, potentially preventing the provision of informed consent orcompliance to study procedure.
  • Pregnant or breast-feeding woman.

Study Design

Total Participants: 50
Study Start date:
July 19, 2023
Estimated Completion Date:
January 15, 2028

Connect with a study center

  • Centre Léon Bérard

    Lyon, 69000
    France

    Active - Recruiting

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