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| Name | Class |
|---|---|
| ERA PERMED | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric cancer patients | gastric cancer patients with histologically confirmed, potentially resectable adenocarcinoma of the stomach or the gastroesophageal junction receiving the standard of medical care in Europe |
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| Measure | Description | Time Frame |
|---|---|---|
| Genomic alterations in tumoral tissue in responders and non-responders | Number of Genomic alterations in tumoral tissue | 36 months |
| 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). | 36 months |
| 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. | 36 months |
| 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) | 36 months |
| Peripheral blood mononuclear cells (PBMCs) and host immunity parameters in responders and non-responders | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiara Molinari | Contact | chiara.molinari@irst.emr.it | ||
| Chiara Zingaretti | Contact | cc.ubsc@irst.emr.it |
| Name | Affiliation | Role |
|---|---|---|
| Chiara Molinari | IRST IRCCS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Regional et Universitaire (CHRU) | Not yet recruiting | Brest | 29200 | France |
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Formalin Fixed Paraffin Embedded (FFPE) tissue, Blood, Fresh Frozen (FF) tissue
| 36 months |
| INSERM, Faculty of Medicine (UMR1078) | Active, not recruiting | Brest | 29200 | France |
| 1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA) | Not yet recruiting | Athens | 11527 | Greece |
|
| IRST IRCCS UO Oncologia | Recruiting | Meldola | 47014 | Italy |
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| AUSL Romagna, UO Oncologia | Active, not recruiting | Ravenna | 48121 | Italy |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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