Status:
RECRUITING
InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Collaborating Sponsors:
ERA PERMED
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-85 years
Brief Summary
Multicentric, exploratory, non-pharmacologic, retrospective/prospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response ...
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 surger...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 22 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04842916
Start Date
September 22 2020
End Date
May 22 2027
Last Update
November 21 2024
Active Locations (5)
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1
Centre Hospitalier Regional et Universitaire (CHRU)
Brest, France, 29200
2
INSERM, Faculty of Medicine (UMR1078)
Brest, France, 29200
3
1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA)
Athens, Greece, 11527
4
IRST IRCCS UO Oncologia
Meldola, Italy, 47014