Colorectal Cancer MetastaticColoBEAMNCT02751177
Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer
A study testing KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA in people with Colorectal Cancer Metastatic, run by Institut de Cancérologie de Lorraine at 11 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 11 sitesFrance
- Study dates
- 25 Mar 2016to 30 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CH Auxerre
Auxerre, 89000
CH Besançon-Hopital Jean Minjoz
Besançon, 25020
CH Chalon Sur Saône-William Morey
Chalon-sur-Saône, 71 321
Centre Georges François Leclerc Dijon
Dijon, 21079
Hopital Belle-Isle-Metz
Metz, 54045
Polyclinique de Gentilly
Nancy, 54000
CHU Reims-Hôpital Robert Debré
Reims, 51092
Polyclinique Courlancy Reims
Reims, 51100
Centre Paul Stauss
Strasbourg, 67065
CHRU Nancy
Vandœuvre-lès-Nancy, 54500
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
Official title: Multicenter Prospective Study Comparing KRAS, NRAS and BRAF Mutation Testing Using OncoBEAM Technique in Plasma vs Conventional Techniques in Formalin Fixed Paraffin Embedded Tissues
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.
Read the detailed 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.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
- Keywords
- KRAS gene mutation, NRAS gene mutation, BRAF gene mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRAS, NRAS et BRAF mutation analysis from circulating plasma DNAGenetic
Also called metastatic colorectal cancer, OncoBEAM
Mutation in plasma DNA vs tumor tissue
| Study group | Role | What they receive |
|---|---|---|
| OncoBEAM | Experimental | KRAS, NRAS and BRAF mutations will be analyzed in circulating plasma DNA using ONCOBEAM technique. Receives: Genetic: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start25 Mar 2016
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MERLIN JEAN LOUIS, Study chair, Institut de Cancérologie de LorraineHARLE ALEXANDRE, Study chair, Institut de Cancérologie de LorraineGAVOILLE CELINE, oncologist, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751177
- Sponsor's protocol ID
- 2015-A01272-47
- Acronym
- ColoBEAM
- Status last verified
- Aug 2018
- First submitted
- 3 Mar 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 41235357
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Study Comparing KRAS, NRAS and BRAF Mutation Testing Using OncoBEAM Technique in Plasma vs Conventional Techniques in Formalin Fixed Paraffin Embedded Tissues
- ClinicalTrials.gov ID
- NCT02751177
- Acronym / sponsor ID
- ColoBEAM / 2015-A01272-47
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- KRAS gene mutation, NRAS gene mutation, BRAF gene mutation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 25 Mar 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OncoBEAM | Experimental | Genetic: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNAKRAS, NRAS and BRAF mutations will be analyzed in circulating plasma DNA using ONCOBEAM technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KRAS, NRAS et BRAF mutation analysis from circulating plasma DNAAlso: metastatic colorectal cancer, OncoBEAMMutation in plasma DNA vs tumor tissue | Genetic | OncoBEAM |
Primary outcome
KRAS, NRAS et BRAF mutational status
Time frame: up to 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Derived from this study: PubMed 41235357Harle 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.
- Individual participant dataSharing planned: Yes
Related trials for Colorectal Cancer Metastatic
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MERLIN JEAN LOUIS study chair
Institut de Cancérologie de Lorraine
HARLE ALEXANDRE study chair
Institut de Cancérologie de Lorraine
GAVOILLE CELINE, oncologist principal investigator
Institut de Cancérologie de Lorraine
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA in people with Colorectal Cancer Metastatic, run by Institut de Cancérologie de Lorraine at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KRAS, NRAS et BRAF mutational status (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02751177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.