NCT02751177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

March 25, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

March 3, 2016

Last Update Submit

August 7, 2018

Conditions

Colorectal Cancer Metastatic

Keywords

KRAS gene mutationNRAS gene mutationBRAF gene mutation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

OncoBEAM

EXPERIMENTAL

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

Interventions

KRAS, NRAS et BRAF mutation analysis from circulating plasma DNAGENETIC

Mutation in plasma DNA vs tumor tissue

Also known as: metastatic colorectal cancer, OncoBEAM
OncoBEAM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CH Auxerre

Auxerre, 89000, France

Location

CH Besançon-Hopital Jean Minjoz

Besançon, 25020, France

Location

CH Chalon Sur Saône-William Morey

Chalon-sur-Saône, 71 321, France

Location

Centre Georges François Leclerc Dijon

Dijon, 21079, France

Location

Hopital Belle-Isle-Metz

Metz, 54045, France

Location

Polyclinique de Gentilly

Nancy, 54000, France

Location

CHU Reims-Hôpital Robert Debré

Reims, 51092, France

Location

Polyclinique Courlancy Reims

Reims, 51100, France

Location

Centre Paul Stauss

Strasbourg, 67065, France

Location

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related Publications (1)

  • Harle A, Gavoille C, Bouche O, Abdelghani MB, Plaza J, Spaeth D, Boudrant A, Ghiringhelli F, Villing AL, Borg C, Rouyer M, Husson M, Gilson P, Salleron J, Lambert A, Merlin JL. Sensitive cell-free DNA assay for accurate detection of RAS and BRAF mutations in liquid biopsies of patients with metastatic colorectal cancer: Final results of the multicentric ColoBEAM study. Oncol Lett. 2025 Oct 30;31(1):13. doi: 10.3892/ol.2025.15366. eCollection 2026 Jan.

    PMID: 41235357DERIVED

Study Officials

  • MERLIN JEAN LOUIS

    Institut de Cancérologie de Lorraine

    STUDY CHAIR

  • HARLE ALEXANDRE

    Institut de Cancérologie de Lorraine

    STUDY CHAIR

  • GAVOILLE CELINE, oncologist

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

April 26, 2016

Study Start

March 25, 2016

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

Locations

FR(11)