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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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 outcome measure(s)
Genomic alterations in tumoral tissue in responders and non-responders — 36 months Number of Genomic alterations in tumoral tissue
Quantitative and qualitative analysis of the tumor microenvironment composition in responders and non-responders — 36 months Analysis of type and size of immune cell subpopulations surrounding primary tumor and extracellular matrix composition on FFPE samples collected at diagnosis and/or surgery. Correlation of data acquired to Participant's response score (TRG or DFS).
Analysis of cell-free DNA (cfDNA) from blood samples in responders and non-responders — 36 months cfDNA will be quantified in Participant's peripheral blood derivatives (plasma, serum) and characterized for Genomic alterations. Samples will be obtained (1) prior to and (2) by completion of chemotherapy in the Neoadjuvant Chemotherapy (NCT) treated cohorts, together with sampling after surgery (3). TRG score will be utilized as measure of response. Accordingly, in NCT-naive cohorts, analysis of samples obtained 1) pre- operatively and 2) by completion of post-operative chemotherapy treatment will be correlated with the respective Disease-Progression clinical indicators.
Analysis of circulating tumor cells (CTC) from blood samples in responders and non-responders. — 36 months gene expression profile of CTC cells (when isolated in sufficient quantity)
Peripheral blood mononuclear cells (PBMCs) and host immunity parameters in responders and non-responders — 36 months Phenotype analysis of representative immune cell subpopulations (i.e. monocytes, helper T cells, cytotoxic T cells, Tregs, Natural Killer (NK) /NKT) in Participants' peripheral blood samples obtained prior- and post- treatment. Combinational analysis of data acquired in correlation with Patient's response score.
Trial sites (5)
Facility
City
Region
Status
Centre Hospitalier Regional et Universitaire (CHRU)
Brest
France
Not Yet Recruiting
INSERM, Faculty of Medicine (UMR1078)
Brest
France
Active Not Recruiting
1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA)
Athens
Greece
Not Yet Recruiting
IRST IRCCS UO Oncologia
Meldola
Italy
Recruiting
AUSL Romagna, UO Oncologia
Ravenna
Italy
Active Not Recruiting
More Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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