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NCT Number: NCT05644431

GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Describe Gastric and Gastroesophageal immunological tumor microenvironment

    Time frame: At least 36 months following inclusion

    Spatial, spectral cytometry, and transcriptomic analyses

Secondary outcomes

  1. Understand the evolution of the immune tumor microenvironment and its spatial structuration through standard neoadjuvant chemotherapy.

    Time frame: At least 36 months following inclusion

  2. 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

  3. 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

  4. Assess the phenotype and functions of circulating immunes cells

    Time frame: At least 36 months following inclusion

  5. 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

Other outcomes

  1. evaluate in patient-derived tumor fragment (ex vivo platform of Centre Léon Bérard), the impact of immune checkpoint inhibitors (ICI) selected from our previous data in order to develop and improve therapeutic strategy

    Time frame: At least 36 months following inclusion

  2. assess MRD using liquid biopsies over standard neoadjuvant and adjuvant treatment.

    Time frame: At least 36 months following inclusion

  3. assess the correlation between ctDNA analysis and i) patient clinical outcome and ii) current prognostic factors (for instance TNM stage with ypTN stage in gastric and oesogastric junction carcinomas).

    Time frame: At least 36 months following inclusion

Study contacts

Contact information is provided by the study sponsor or research team.

Clélia COUTZAC, MD

CONTACT

[email protected]

04 78 78 60 20

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study 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

Acronym: GOTIM

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 9, 2022
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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