NCT04842916 InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer
| NCT ID | NCT04842916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS |
| Condition | Gastric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2020-09-22 |
| Primary Completion | 2027-05-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2020-09-22 with a primary completion date of 2027-05-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Chiara Molinari
✉ chiara.molinari@irst.emr.itChiara Molinari
STUDY CHAIR
IRST IRCCS
Frequently Asked Questions
Who can join the NCT04842916 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04842916 currently recruiting?
Yes, NCT04842916 is actively recruiting participants. Contact the research team at chiara.molinari@irst.emr.it for enrollment information.
Where is the NCT04842916 trial being conducted?
This trial is being conducted at Brest, France, Brest, France, Athens, Greece, Meldola, Italy and 1 additional location.
Who is sponsoring the NCT04842916 clinical trial?
NCT04842916 is sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. The principal investigator is Chiara Molinari at IRST IRCCS. The trial plans to enroll 250 participants.
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