Molecular Profiling of Colorectal Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- association between gene mutational status and overall survival [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 [24 months]
the time from colorectal cancer diagnosis to the first date of documented disease progression, death or last contact, whichever occurs first
Secondary Outcome Measures
- Descriptives [24 months]
Association of any gene mutation tumor pathological stages.
- Descriptives [24 months]
Association of any gene mutation tumor budding.
- Descriptives [24 months]
Association of any gene mutation with microstatellite instability.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Surgically resected early-stage (II-III) colorectal cancer
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Availability of biological material
Exclusion Criteria:
- Metastatic disease (stage IV) at initial diagnosis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hellenic Cooperative Oncology Group | Athens | Greece | 11526 |
Sponsors and Collaborators
- Hellenic Cooperative Oncology Group
Investigators
- Study Chair: George Fountzilas, Prof, Hellenic Cooperative Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
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- TR6N/19