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

April 9, 2021 updated by: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29200
        • Centre Hospitalier Regional et Universitaire (CHRU)
      • Brest, France, 29200
        • INSERM, Faculty of Medicine (UMR1078)
  • Greece
      • Athens, Greece, 11527
        • 1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA)
  • Italy
      • Meldola, Italy, 47014
        • IRST IRCCS UO Oncologia
      • Ravenna, Italy, 48121
        • AUSL Romagna, UO Oncologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genomic alterations in tumoral tissue in responders and non-responders
Time Frame: 36 months
Number of Genomic alterations in tumoral tissue
36 months
Quantitative and qualitative analysis of the tumor microenvironment composition in responders and non-responders
Time Frame: 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).
36 months
Analysis of cell-free DNA (cfDNA) from blood samples in responders and non-responders
Time Frame: 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.
36 months
Analysis of circulating tumor cells (CTC) from blood samples in responders and non-responders.
Time Frame: 36 months
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
Time Frame: 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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological status of patients in relation to therapy response
Time Frame: 36 months
Psychological status of patients in relation to therapy response evaluated by a psychologist through structured interview
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Collaborators

ERA PERMED

Investigators

  • Study Chair: Chiara Molinari, Irst Irccs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2020

Primary Completion (Anticipated)

September 22, 2023

Study Completion (Anticipated)

September 22, 2023

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

April 9, 2021

First Posted (Actual)

April 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 9, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRSTB111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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