Clinical trial NCT04842916: InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer
Official title: InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Keywords: Gastric cancer, Chemotherapy, Response, Personalized medicine
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
Collaborators: name: ERA PERMED
First posted: 2021-04-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with potentially resectable adenocarcinoma of the stomach (GC) or the gastric-esophageal junction (GEJ) who received pre- or peri-operative chemotherapy or up-front surgery followed by chemotherapy

Brief summary: 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.

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

Primary outcomes:
measure: Genomic alterations in tumoral tissue in responders and non-responders
timeFrame: 36 months
measure: Quantitative and qualitative analysis of the tumor microenvironment composition in responders and non-responders
timeFrame: 36 months
measure: Analysis of cell-free DNA (cfDNA) from blood samples in responders and non-responders
timeFrame: 36 months
measure: Analysis of circulating tumor cells (CTC) from blood samples in responders and non-responders.
timeFrame: 36 months
measure: Peripheral blood mononuclear cells (PBMCs) and host immunity parameters in responders and non-responders
timeFrame: 36 months
Secondary outcomes:
measure: Psychological status of patients in relation to therapy response
timeFrame: 36 months
Other outcomes:
Locations:
city: Brest
country: France
facility: Centre Hospitalier Regional et Universitaire (CHRU)
city: Brest
country: France
facility: INSERM, Faculty of Medicine (UMR1078)
city: Athens
country: Greece
facility: 1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA)
city: Meldola
country: Italy
facility: IRST IRCCS UO Oncologia
city: Ravenna
country: Italy
facility: AUSL Romagna, UO Oncologia
Study officials:
affiliation: IRST IRCCS
name: Chiara Molinari
role: STUDY_CHAIR
References: