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Trial Title:
GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)
NCT ID:
NCT05644431
Condition:
GastroEsophageal Cancer
Conditions: Keywords:
junctional adenocarcinomas
immune microenvironment
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Adult patients with localised non-metastatic operable gastric and oeasogatric junction
adenocarcinoma, stage IB à III, treated with standard neoadjuvant therapy and by surgery.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69000
Country:
France
Status:
Recruiting
Contact:
Last name:
Clélia COUTZAC, MD
Phone:
04 78 78 60 20
Email:
clelia.coutzac@lyon.unicancer.fr
Start date:
July 19, 2023
Completion date:
January 15, 2028
Lead sponsor:
Agency:
Centre Leon Berard
Agency class:
Other
Source:
Centre Leon Berard
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05644431
