Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04842916

InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Regional et Universitaire (CHRU), Brest, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Genomic alterations in tumoral tissue in responders and non-responders

    Time frame: 36 months

    Number of Genomic alterations in tumoral tissue

  2. 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).

  3. 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.

  4. 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)

  5. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Molinari

CONTACT

[email protected]

Chiara Zingaretti

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Other

Collaborators

  • ERA PERMED

Registry information

Acronym: GRAMMY

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2021
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.