RecruitingNCT04842916

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


Sponsor

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

Enrollment

250 participants

Start Date

Sep 22, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

  • 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 Criteria10

  • 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

Locations(5)

Centre Hospitalier Regional et Universitaire (CHRU)

Brest, France

INSERM, Faculty of Medicine (UMR1078)

Brest, France

1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA)

Athens, Greece

IRST IRCCS UO Oncologia

Meldola, Italy

AUSL Romagna, UO Oncologia

Ravenna, Italy

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NCT04842916


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