Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer (CircuLOR-1)

August 7, 2018 updated by: Institut de Cancérologie de Lorraine

Prospective Study of Technical Optimization of the Detection of KRAS Mutations, BRAF and NRAS by Next Generation Sequencing on Tumor DNA Circulating in Metastatic Colorectal Cancer.

The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Vandoeuvre-lès-Nancy, France, 54500
        • Institut de Cancérologie de Lorraine

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

Description

Inclusion Criteria:

  • Patients with metastatic or locally advanced colorectal carcinoma with a KRAS, BRAF or NRAS mutation
  • Age ≥ 18 years
  • Patient information and written informed consent form signed
  • Patient must be affiliated to a social security system

Exclusion Criteria:

  • Patients whose health-cons indicates a blood sample 10mL
  • Age < 18 years
  • Pregnant or breast feeding females
  • Persons deprived of liberty or under supervision

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CircuLOR-1
KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAF (exon 15) mutations
Other: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
10 ml blood sample
Other Names:
  • NGS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Optimization of KRAS, BRAF and NRAS mutations detection
Time Frame: 1 day
Optimize the detection of mutations of KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAf (exon 15) genes, using the next-generation sequencing technology from circulating tumor DNA in patients with metastatic colorectal cancer.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KRAS, NRAS et BRAF mutational status
Time Frame: 1 day
Compare the results of KRAS NRAS and BRAF genes genotyping obtained from circulating tumor DNA to that achieved by the current gold standard (paraffin-embedded).
1 day

Collaborators and Investigators

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

Sponsor

Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: GAVOILLE CELINE, MD, Institut de Cancérologie de Lorraine
  • Study Chair: HARLE ALEXANDRE, Institut de Cancérologie de Lorraine

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)

February 3, 2016

Primary Completion (Actual)

January 5, 2017

Study Completion (Actual)

January 19, 2017

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00922-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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