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Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer (ColoBEAM)

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ClinicalTrials.gov Identifier: NCT02751177
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Genetic: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : March 25, 2016
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OncoBEAM
KRAS, NRAS and BRAF mutations will be analyzed in circulating plasma DNA using ONCOBEAM technique.
Genetic: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
Mutation in plasma DNA vs tumor tissue
Other Names:
  • metastatic colorectal cancer
  • OncoBEAM




Primary Outcome Measures :
  1. KRAS, NRAS et BRAF mutational status [ Time Frame: up to 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751177


Locations
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France
CH Auxerre
Auxerre, France, 89000
CH Besançon-Hopital Jean Minjoz
Besançon, France, 25020
CH Chalon Sur Saône-William Morey
Chalon Sur Saône, France, 71 321
Centre Georges François Leclerc Dijon
Dijon, France, 21079
Hopital Belle-Isle-Metz
Metz, France, 54045
Polyclinique de Gentilly
Nancy, France, 54000
CHU Reims-Hôpital Robert Debré
Reims, France, 51092
Polyclinique Courlancy Reims
Reims, France, 51100
Centre Paul Stauss
Strasbourg, France, 67065
CHRU Nancy
Vandœuvre-lès-Nancy, France, 54500
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Investigators
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Study Chair: MERLIN JEAN LOUIS Institut de Cancérologie de Lorraine
Study Chair: HARLE ALEXANDRE Institut de Cancérologie de Lorraine
Principal Investigator: GAVOILLE CELINE, oncologist Institut de Cancérologie de Lorraine

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Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT02751177     History of Changes
Other Study ID Numbers: 2015-A01272-47
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Institut de Cancérologie de Lorraine:
KRAS gene mutation
NRAS gene mutation
BRAF gene mutation

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases