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RecruitingNCT05644431GOTIMUpdated Aug 30, 2023

GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)

An observational study in GastroEsophageal Cancer, sponsored by Centre Leon Berard. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by Centre Leon Berard · Observational

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • GastroEsophageal Cancer

Keywords

  • junctional adenocarcinomas
  • immune microenvironment
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In context

Lead sponsor

Centre Leon Berard is the lead sponsor of 206 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with localised non-metastatic operable gastric and oeasogatric junction adenocarcinoma, stage IB à III, treated with standard neoadjuvant therapy and by surgery.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Gastric and gastroesophageal junctional adenocarcinomas

    Patient under standard chemotherapy in localized and resectable gastric and gastroesophageal junctional adenocarcinomas

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What researchers measure

Primary outcomes

  1. Describe Gastric and Gastroesophageal immunological tumor microenvironment

    Spatial, spectral cytometry, and transcriptomic analyses

    Time frame: At least 36 months following inclusion

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

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05644431
Lead sponsor
Centre Leon Berard
Responsible party
Sponsor
First posted
Dec 9, 2022
Start date
Jul 19, 2023
Primary completion
Jan 15, 2028 (estimated)
Completion
Jan 15, 2028 (estimated)
Last update
Aug 30, 2023

Study contacts

Clélia COUTZAC, MD
Contact
clelia.coutzac@lyon.unicancer.fr
04 78 78 60 20
Clélia COUTZAC, MD
principal investigator · Centre Leon Berard

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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