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.
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
Age < 18 years
Early Gastric Cancer and T2 (if N0)
Linitis plastica
Positive peritoneal cytology or peritoneal involvement
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
Cohort
Other
Not listed
Genomic alterations in tumoral tissue in responders and non-responders
Number of Genomic alterations in tumoral tissue
Quantitative and qualitative analysis of the tumor microenvironment composition in responders and non-responders
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
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.
gene expression profile of CTC cells (when isolated in sufficient quantity)
Psychological status of patients in relation to therapy response
Psychological status of patients in relation to therapy response evaluated by a psychologist through structured interview
Click on the lead sponsor to view all of their trials.
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Lead sponsor
ERA PERMED
Collaborator
