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

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metastatic Colorectal Cancer focused on measuring colorectal cancer, Kras mutation, Nras mutation, Braf mutation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut de Cancerologie de Lorraine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CircuLOR-1

Arm Description

KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAF (exon 15) mutations

Outcomes

Primary Outcome Measures

Technical Optimization of KRAS, BRAF and NRAS mutations detection
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.

Secondary Outcome Measures

KRAS, NRAS et BRAF mutational status
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).

Full Information

First Posted
July 6, 2016
Last Updated
August 7, 2018
Sponsor
Institut de Cancérologie de Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT02827565
Brief Title
Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer
Acronym
CircuLOR-1
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 3, 2016 (Actual)
Primary Completion Date
January 5, 2017 (Actual)
Study Completion Date
January 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
colorectal cancer, Kras mutation, Nras mutation, Braf mutation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CircuLOR-1
Arm Type
Experimental
Arm Description
KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAF (exon 15) mutations
Intervention Type
Other
Intervention Name(s)
KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
Other Intervention Name(s)
NGS
Intervention Description
10 ml blood sample
Primary Outcome Measure Information:
Title
Technical Optimization of KRAS, BRAF and NRAS mutations detection
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
KRAS, NRAS et BRAF mutational status
Description
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).
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GAVOILLE CELINE, MD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HARLE ALEXANDRE
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Study Chair
Facility Information:
Facility Name
Institut de Cancerologie de Lorraine
City
Vandoeuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer

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