InteGRAtive Analysis of tuMor, Microenvironment, immunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer

Gastric Cancer Clinical Trial

— GRAMMY  

Official title:

InteGRAtive Analysis of tuMor, Microenvironment, immunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04842916
• Other study ID #: IRSTB111
• Status: Active, not recruiting
• Start date: September 22, 2020
• Est. completion date: September 22, 2023

Study information

• Verified date: April 2021
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
France	Centre Hospitalier Regional et Universitaire (CHRU)	Brest
France	INSERM, Faculty of Medicine (UMR1078)	Brest
Greece	1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA)	Athens
Italy	IRST IRCCS UO Oncologia	Meldola
Italy	AUSL Romagna, UO Oncologia	Ravenna

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori	ERA PERMED

Countries where clinical trial is conducted

France,  Greece,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genomic alterations in tumoral tissue in responders and non-responders	Number of Genomic alterations in tumoral tissue	36 months
Primary	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
Primary	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
Primary	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
Primary	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.	36 months
Secondary	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