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

Metastatic Colorectal Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827565
• Other study ID #: 2015-A00922-47
• Status: Completed
• Phase: N/A
• Start date: February 3, 2016
• Est. completion date: January 19, 2017

Study information

• Verified date: August 2018
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 19, 2017
• Est. primary completion date: January 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
10 ml blood sample

Locations

Country	Name	City	State
France	Institut de Cancerologie de Lorraine	Vandoeuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	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).	1 day