Clinical trial NCT04863768: Molecular Profiling of Colorectal Cancer
Official title: Molecular Profiling of Colorectal Cancer: A Translational Research Study With a Next Generation Sequencing Panel.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Colon Cancer
Colon Adenocarcinoma
Keywords: Colon
Translational research
Gene panel
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent surgical resection of early-stage (II-III) colorectal cancer

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.


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

Primary outcomes:
measure: association between gene mutational status and overall survival
timeFrame: 24 months
measure: association between gene mutational status and disease-free survival
timeFrame: 24 months
Secondary outcomes:
measure: Descriptives
timeFrame: 24 months
measure: Descriptives
timeFrame: 24 months
measure: Descriptives
timeFrame: 24 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hellenic Cooperative Oncology Group
Study officials:
affiliation: Hellenic Cooperative Oncology Group
name: George Fountzilas, Prof
role: STUDY_CHAIR
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