NCT04842916Recruiting
InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer
Source: ClinicalTrials.gov · Last updated 21 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 23 Dec 2020
- Start date
- 22 Sept 2020
- Primary completion date
- 22 May 2027
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04842916
What you commit to
- Study type: Observational
- Planned participants: 250
- From 22 Sept 2020 to the primary completion date, 22 May 2027
- 5 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Early Gastric Cancer and T2 (if N0)
- Patient withdrawing from treatment plan whilst under therapy due to patient co-morbidities or failure to comply with clinical counselling
- Patients with mental illness hindering the capacity to provide precise information in questionnaires or successfully comply with caregiver's recommendations
Age
- Age \< 18 years
Other
- 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
- Patients with underlying pathologies rendering sampling of biological material either as endangering patient's clinical status or as unusable
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| INSERM, Faculty of Medicine (UMR1078) Coordinator of this site? Confirm its status | Brest | France | Active, not recruiting |
| Centre Hospitalier Regional et Universitaire (CHRU) Coordinator of this site? Confirm its status | Brest | France | Not yet recruiting |
| 1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA) Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| IRST IRCCS UO Oncologia Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| AUSL Romagna, UO Oncologia Coordinator of this site? Confirm its status | Ravenna | Italy | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.