Clinical trial Recruiting at 1 site Observational Ages 18 to 85

Analyzing factors for predicting chemotherapy response in gastric cancer

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

Run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · NCT04842916 · Data updated 2026-11-12

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.

More Gastric Cancer trials

Quick facts

Study typeObservational
Ages18 Years to 85 Years
SexAll
Enrollment250 (estimated)
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Academic / other
Drugs / interventionschemotherapy
Locations5 sites (Brest and 4 other locations)
StatusRecruiting
StartedSeptember 22, 2020
Main results expectedMay 22, 2027
Study endsMay 22, 2027
Registry record updatedNovember 21, 2024
Trial IDNCT04842916 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in using interdisciplinary approaches to predict treatment responses in cancer, suggesting potential success for this novel methodology.

Who can join: the full rules

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 it's running

  • IRST IRCCS UO Oncologia
    Meldola, Italy
    Recruiting
  • 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
  • AUSL Romagna, UO Oncologia
    Ravenna, Italy
    Active not recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.