Molecular Profiling of Colorectal Cancer

April 26, 2021 updated by: Hellenic Cooperative Oncology Group

Molecular Profiling of Colorectal Cancer: A Translational Research Study With a Next Generation Sequencing Panel.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Athens, Greece, 11526
        • Recruiting
        • Hellenic Cooperative Oncology Group
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent surgical resection of early-stage (II-III) colorectal cancer

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Metastatic disease (stage IV) at initial diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptives
Time Frame: 24 months
Association of any gene mutation tumor pathological stages.
24 months
Descriptives
Time Frame: 24 months
Association of any gene mutation tumor budding.
24 months
Descriptives
Time Frame: 24 months
Association of any gene mutation with microstatellite instability.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Cooperative Oncology Group

Investigators

  • Study Chair: George Fountzilas, Prof, Hellenic Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

March 12, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR6N/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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