InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gastric Cancer. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Greece, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Multicentric, exploratory, non-pharmacologic, retrospective/prospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response to chemotherapy in gastric cancer patients.
Detailed description
Gastric cancer (GC) is a complex disease that represents the fifth most common malignancy in the world and the third leading cause of cancer death in both sexes. Chemotherapy (CT) combined with surgery represents the standard of care for stages II-III GC, but the efficacy of such treatments is still limited for many patients. It is mandatory to develop novel strategies aimed at identifying predictive markers, as well as deciphering the impact of the psychological-social and cultural environment of each patient on the outcome. GRAMMY study proposes a novel interdisciplinary approach integrating high impact basic, translational and psychological/sociological research towards developing an optimized patient stratification tool for the early prediction of therapy-resistant GC patient groups.
Primary outcome measures
- Genomic alterations in tumoral tissue in responders and non-responders [Time frame: 36 months]
- Quantitative and qualitative analysis of the tumor microenvironment composition in responders and non-responders [Time frame: 36 months]
- Analysis of cell-free DNA (cfDNA) from blood samples in responders and non-responders [Time frame: 36 months]
- Analysis of circulating tumor cells (CTC) from blood samples in responders and non-responders. [Time frame: 36 months]
- Peripheral blood mononuclear cells (PBMCs) and host immunity parameters in responders and non-responders [Time frame: 36 months]
Secondary outcome measures (1)
- Psychological status of patients in relation to therapy response [Time frame: 36 months]
Eligibility criteria
Inclusion criteria
- Patients with diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach (GC) or the gastric-esophageal junction (GEJ) treated with the standard regimens (5-Fluoro-Uracil or Capecitabine + Oxaliplatin +/- Docetaxel)
- Participant is willing and able to give informed consent for participation in the study (prospective and retrospective cohort) or Substitutive Informed Consent Declaration Form will be subscribed by the PI for patients that are not reachable
- Male or Female, aged >18 years
- Availability of tissue samples and clinico-pathological data for retrospective cohort
Exclusion criteria
- Age < 18 years
- Early Gastric Cancer and T2 (if N0)
- Linitis plastica
- Positive peritoneal cytology or peritoneal involvement
- Distant metastases
- Patient refusal to participate
- Patient refusal to the use of their own samples for research
- Patient withdrawing from treatment plan whilst under therapy due to patient co-morbidities or failure to comply with clinical counselling
- Patients with underlying pathologies rendering sampling of biological material either as endangering patient's clinical status or as unusable
- Patients with mental illness hindering the capacity to provide precise information in questionnaires or successfully comply with caregiver's recommendations
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Centre Hospitalier Regional et Universitaire (CHRU) — Brest
- INSERM, Faculty of Medicine (UMR1078) — Brest
Italy · 2 centers
- IRST IRCCS UO Oncologia — Meldola
- AUSL Romagna, UO Oncologia — Ravenna
Greece · 1 center
- 1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA — Athens
Identifiers
NCT: NCT04842916 · IRSTB111