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)
View Full Details on ClinicalTrials.gov
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NCT04842916
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