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OpenTrials
Completed

NCT Number: NCT02827565

Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations 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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA

Other

10 ml blood sample

Other names: NGS

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study 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.

Acronym: CircuLOR-1

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2016
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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