Back to resultsDetection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer (ColoBEAM)
Primary Purpose
Colorectal Cancer Metastatic
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer Metastatic focused on measuring KRAS gene mutation, NRAS gene mutation, BRAF gene mutation
Eligibility Criteria
Inclusion Criteria:
- Adult subjects with newly diagnosed, anti EGFR treatment naïve metastatic colorectal cancer
- Standard of Care RAS/RAF tests performed on FFPE tumor sample as part of routine
- Patient information and written informed consent form signed
- Patient must be affiliated to a social security system
- Age : 18 years and older
Exclusion Criteria:
- Patient bearing non-metastatic colorectal cancer
- Patient with local relapse only
- Patient with exclusive nodal metastases
- Patient whose health contraindicates a 30 ml blood sample
- Blood transfusion within 1 week prior blood collection
- Patient having received any chemotherapy or / and radiotherapy within 15 days prior to blood collection
- History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix
- Persons deprived of liberty or under supervision
Sites / Locations
- CH Auxerre
- CH Besançon-Hopital Jean Minjoz
- CH Chalon Sur Saône-William Morey
- Centre Georges François Leclerc Dijon
- Hopital Belle-Isle-Metz
- Polyclinique de Gentilly
- CHU Reims-Hôpital Robert Debré
- Polyclinique Courlancy Reims
- Centre Paul Stauss
- CHRU Nancy
- Institut de Cancérologie de Lorraine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OncoBEAM
Arm Description
KRAS, NRAS and BRAF mutations will be analyzed in circulating plasma DNA using ONCOBEAM technique.
Outcomes
Primary Outcome Measures
KRAS, NRAS et BRAF mutational status
Compare the results of KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAF (V600) genes genotyping using OncoBeam technique in blood samples with results achieved routinely by the molecular genetics platforms of the recruiting centers.
Secondary Outcome Measures
Full Information
NCT ID
NCT02751177
First Posted
March 3, 2016
Last Updated
August 7, 2018
Sponsor
Institut de Cancérologie de Lorraine
1. Study Identification
Unique Protocol Identification Number
NCT02751177
Brief Title
Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer
Acronym
ColoBEAM
Official Title
Multicenter Prospective Study Comparing KRAS, NRAS and BRAF Mutation Testing Using OncoBEAM Technique in Plasma vs Conventional Techniques in Formalin Fixed Paraffin Embedded Tissues
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 25, 2016 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 30, 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
Yes
5. Study Description
Brief Summary
RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™ technique with those achieved using the standard genotyping techniques and formalin-fixed paraffin embedded samples.
Detailed Description
The study will be proposed to all patients with a metastatic colorectal cancer.
Study information will be given to the patient during a routine medical examination. The patient will be included after checking inclusion criteria and signature of the informed consent form
Blood sampling (30 ml) will be performed before the initiation of the first line metastatic chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic
Keywords
KRAS gene mutation, NRAS gene mutation, BRAF gene mutation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OncoBEAM
Arm Type
Experimental
Arm Description
KRAS, NRAS and BRAF mutations will be analyzed in circulating plasma DNA using ONCOBEAM technique.
Intervention Type
Genetic
Intervention Name(s)
KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
Other Intervention Name(s)
metastatic colorectal cancer, OncoBEAM
Intervention Description
Mutation in plasma DNA vs tumor tissue
Primary Outcome Measure Information:
Title
KRAS, NRAS et BRAF mutational status
Description
Compare the results of KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAF (V600) genes genotyping using OncoBeam technique in blood samples with results achieved routinely by the molecular genetics platforms of the recruiting centers.
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects with newly diagnosed, anti EGFR treatment naïve metastatic colorectal cancer
Standard of Care RAS/RAF tests performed on FFPE tumor sample as part of routine
Patient information and written informed consent form signed
Patient must be affiliated to a social security system
Age : 18 years and older
Exclusion Criteria:
Patient bearing non-metastatic colorectal cancer
Patient with local relapse only
Patient with exclusive nodal metastases
Patient whose health contraindicates a 30 ml blood sample
Blood transfusion within 1 week prior blood collection
Patient having received any chemotherapy or / and radiotherapy within 15 days prior to blood collection
History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix
Persons deprived of liberty or under supervision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MERLIN JEAN LOUIS
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
HARLE ALEXANDRE
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
GAVOILLE CELINE, oncologist
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Auxerre
City
Auxerre
ZIP/Postal Code
89000
Country
France
Facility Name
CH Besançon-Hopital Jean Minjoz
City
Besançon
ZIP/Postal Code
25020
Country
France
Facility Name
CH Chalon Sur Saône-William Morey
City
Chalon Sur Saône
ZIP/Postal Code
71 321
Country
France
Facility Name
Centre Georges François Leclerc Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital Belle-Isle-Metz
City
Metz
ZIP/Postal Code
54045
Country
France
Facility Name
Polyclinique de Gentilly
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
CHU Reims-Hôpital Robert Debré
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Polyclinique Courlancy Reims
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Centre Paul Stauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
CHRU Nancy
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54519
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer
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