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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02751177
Other study ID # 2015-A01272-47
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 25, 2016
Est. completion date May 30, 2017

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 236
Est. completion date May 30, 2017
Est. primary completion date May 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
Mutation in plasma DNA vs tumor tissue

Locations

Country Name City State
France CH Auxerre Auxerre
France CH Besançon-Hopital Jean Minjoz Besançon
France CH Chalon Sur Saône-William Morey Chalon Sur Saône
France Centre Georges François Leclerc Dijon Dijon
France Hopital Belle-Isle-Metz Metz
France Polyclinique de Gentilly Nancy
France CHU Reims-Hôpital Robert Debré Reims
France Polyclinique Courlancy Reims Reims
France Centre Paul Stauss Strasbourg
France CHRU Nancy Vandœuvre-lès-Nancy
France Institut de Cancérologie de Lorraine Vandœuvre-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 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. up to 6 months
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