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

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ClinicalTrials.gov Identifier: NCT02827565
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Actual Study Start Date : February 3, 2016
Actual Primary Completion Date : January 5, 2017
Actual Study Completion Date : January 19, 2017

Resource links provided by the National Library of Medicine


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 Name: NGS




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



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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:

  • 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

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): NCT02827565


Locations
France
Institut de Cancerologie de Lorraine
Vandoeuvre-lès-Nancy, France, 54500
Sponsors and Collaborators
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

Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT02827565     History of Changes
Other Study ID Numbers: 2015-A00922-47
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut de Cancérologie de Lorraine:
colorectal cancer
Kras mutation
Nras mutation
Braf mutation

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