Molecular Profiling of Colorectal Cancer: A Translational Research Study With a Next Generation Sequencing Panel.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Hellenic Cooperative Oncology Group
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- association between gene mutational status and overall survival
- Last Updated
- 5 years ago
Overview
Brief Summary
In this translational research study, Formalin-Fixed-Paraffin-Embedded (FFPE) tumor tissue blocks from patients with early-stage (II-III) colorectal cancer will be assessed for a comprehensive cancer gene panel from NIPD Genetics (https://www.nipd.com/) targeting regions in 37 clinically relevant cancer genes.
The colorectal cancer panel includes an extended list of clinically relevant genes, designed to target clinically actionable and clinically significant mutations that will provide physicians with genetic information regarding a) prediction of the patient's response to targeted therapy, b) prognosis, that is, prediction of clinical outcome, c) diagnosis and molecular classification of colorectal cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Surgically resected early-stage (II-III) colorectal cancer
- •Availability of biological material
Exclusion Criteria
- •Metastatic disease (stage IV) at initial diagnosis
Outcomes
Primary Outcomes
association between gene mutational status and overall survival
Time Frame: 24 months
the time from diagnosis to the date of death (from any cause). Alive patients and patients lost to follow-up will be censored at the date of last follow-up
association between gene mutational status and disease-free survival
Time Frame: 24 months
the time from colorectal cancer diagnosis to the first date of documented disease progression, death or last contact, whichever occurs first
Secondary Outcomes
- Descriptives(24 months)