Analyzing factors for predicting chemotherapy response in gastric cancer
InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer
This study is trying to find out which factors can help predict how well patients with gastric cancer will respond to chemotherapy, so that doctors can better tailor treatments for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Brest and 4 other locations) |
| Trial ID | NCT04842916 on ClinicalTrials.gov |
What this trial studies
This multicentric, exploratory study aims to identify molecular, cellular, and psychological-sociological variables that predict how patients with gastric cancer respond to chemotherapy. By integrating basic, translational, and psychological research, the study seeks to develop a tool for optimizing patient stratification and early prediction of therapy-resistant groups. It includes both retrospective and prospective cohorts of patients diagnosed with potentially resectable gastric adenocarcinoma. The study will analyze tissue samples and clinical data to uncover predictive markers and the impact of the patient's environment on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with histologically confirmed, potentially resectable gastric adenocarcinoma or gastric-esophageal junction cancer who are undergoing standard chemotherapy regimens.
Not a fit: Patients with early-stage gastric cancer, distant metastases, or those who refuse participation or use of their samples for research may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for gastric cancer patients, improving their response to chemotherapy.
How similar studies have performed: Other studies have shown promise in using interdisciplinary approaches to predict treatment responses in cancer, suggesting potential success for this novel methodology.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brest and 4 other locations
- Centre Hospitalier Regional et Universitaire (CHRU) — Brest, France (Not_yet_recruiting)
- INSERM, Faculty of Medicine (UMR1078) — Brest, France (Active_not_recruiting)
- 1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA) — Athens, Greece (Not_yet_recruiting)
- IRST IRCCS UO Oncologia — Meldola, Italy (Recruiting)
- AUSL Romagna, UO Oncologia — Ravenna, Italy (Active_not_recruiting)
Study contacts
- Study coordinator: Chiara Molinari
- Email: chiara.molinari@irst.emr.it
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.