Molecular Profiling of Colorectal Cancer

• Conditions: Colorectal Cancer; Colon Cancer; Colon Adenocarcinoma

• Registration Number: NCT04863768
• Lead Sponsor: Hellenic Cooperative Oncology Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-04-26
• Last Update Submitted: 2021-04-26
• Study First Posted: 2021-04-28
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Surgically resected early-stage (II-III) colorectal cancer
• Availability of biological material

Exclusion Criteria

• Metastatic disease (stage IV) at initial diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Descriptives	24 months	Association of any gene mutation with microstatellite instability.

Trial Locations

Locations (1)

Hellenic Cooperative Oncology Group; 🇬🇷 Athens, Greece