Status:
ACTIVE_NOT_RECRUITING
Deciphering the Molecular Traits of Non-canonical Responders to Advance Personalized Therapy in Gastric Cancer
Lead Sponsor:
Regina Elena Cancer Institute
Conditions:
Metastatic Gastric Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Retrospective-prospective observational study in which a novel whole-exome sequencing (WES) approach will be used in association with whole-transcriptome sequencing (WTS) to analyze two independent an...
Detailed Description
A workflow specifically designed for this project will be adopted, using clinical outcomes as a benchmark for comparative analyses, to generate a molecular classifier applicable to all patients affect...
Eligibility Criteria
Inclusion
- Age \>18 years;
- Histological diagnosis of locally advanced or metastatic gastric cancer (GC) or gastroesophageal junction carcinoma (EJC);
- Adequate biological material for molecular analysis, collected (at surgery or by biopsy) before the administration of any anti-tumor treatment (chemotherapy and/or radiotherapy);
- ECOG PS 0-2;
- Adequate hematological, hepatic and renal function;
- Measurable disease according to RECIST criteria;
- Written informed consent.
Exclusion
- Previous chemotherapy for metastatic disease;
- Comorbidities not controlled with adequate medical therapy;
- Brain metastases;
- Patient unable to give adequate consent to the study.
Key Trial Info
Start Date :
January 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 10 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06877910
Start Date
January 10 2021
End Date
January 10 2026
Last Update
March 14 2025
Active Locations (1)
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1
IRCCS National Cancer institute
Rome, Italy, 00144