Metastatic Colorectal CancerEmutRASNCT03908788
Detection of the Emergence of RAS (Rat Sarcoma Viral Oncogene Homolog) Mutations in Circulating DNA (Deoxyribonucleic Acid) in Patients With mCRC (Metastatic Colorectal Cancer) During Treatment With Anti-EGFR (Epidermal Growth Factor Receptor) Therapy
A study testing Intplex test in people with Metastatic Colorectal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 sites in France.
Trial summary
The analysis of circulating DNA (Deoxyribonucleic acid) to identify potential resistance mechanisms during anti-EGFR (epidermal growth factor receptor) treatment is of great interest, as evidenced by the recent journal published by Corcoran in the prestigious New England Journal of Medicine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Intplex test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Jul 2018to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient with histologically confirmed metastatic colorectal cancer
- Patient treated in the first line by one of the treatments below and according to a bi-monthly schema for cetuximab: FOLFIRI (elvorin + 5 Fluorouracil + irinotecan) ou FOLFOX (elvorin + 5 Fluorouracil + oxalplatin) + Cetuximab* (Erbitux) ; FOLFIRI ou FOLFOX + Panitumumab (Vectibix); FOLFIRINOX ou FOLFOXIRI ((elvorin + 5 Fluorouracil + oxaliplatin + irinotecan) + Cetuximab* (Erbitux); FOLFIRINOX ou FOLFOXIRI + Panitumumab (Vectibix) For patient treated cetuximab administration will be bi-monthly
- Patient with at least one evaluable metastatic target according to RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)
- Wild RAS (rat sarcoma viral oncogene homolog) status detected by standard tissue test, on primary tumor and / or metastasis
- Wild BRAF (murine sarcoma viral oncogene homolog B) status detected by standard tissue test, on primary tumor and / or metastasis
- Man or woman> 18 years old
- Signed informed consent before any specific procedure to study
- Patient affiliated to the social security or equivalent
Who cannot join
- Previous treatment with an anti-EGFR (epidermal growth factor receptor)
- Patient with a multifocal primary tumor
- RAS (rat sarcoma viral oncogene homolog) status mutated or not detectable on tissue analysis
- BRAF (murine sarcoma viral oncogene homolog B) status mutated or undetectable on tissue analysis
- Patient receiving adjuvant chemotherapy or radiotherapy within <14 days
- History of other cancer in the last 5 years (except in-situ carcinoma of the cervix and cutaneous carcinoma excluding melanoma treated optimally)
Show all 10Show fewer
- Blood transfusion (whole blood, red blood cell, platelets...) in the previous week
- Patients with psychological, familial, sociological or geographic conditions potentially not favorable to the good observance of the study protocol and the follow-up
- Legal incapacity or limited legal capacity
- Participation in another interventional clinical trial - biomedical research (therapeutic strategy type) is not excluded provided that it is use an Anti-EGFR with a AMM (marketing authorization), (Cetuximab - Panitumumab) with a dose and a standard administration rhythm (according to the AMM).
Trial locations and contacts
2 sites in 1 country.
France2 sites
ICM Val d'Aurelle
Montpellier, Montpellier, 34298
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, 34298
About this study
Official title: Detection of the Emergence of RAS (Rat Sarcoma Viral Oncogene Homolog) Mutations in Circulating DNA (Deoxyribonucleic Acid) in Patients With Metastatic Colorectal Cancer During Treatment With Anti-EGFR (Epidermal Growth Factor Receptor) Therapy
The analysis of circulating DNA (Deoxyribonucleic acid) to identify potential resistance mechanisms during anti-EGFR (epidermal growth factor receptor) treatment is of great interest, as evidenced by the recent journal published by Corcoran in the prestigious New England Journal of Medicine.
EmutRAS is one of the first studies that will specifically and prospectively evaluate the RAS mutational switch and its impact on the efficiency of the 1st line processing.
Read the detailed description
The primary study objective is the Detection of RAS mutational (rat sarcoma viral oncogene homolog) "switch" in circulating DNA by Intplex® test in mCRC (metastatic colorectal cancer) patients treated with antibody anti-EGFR (epidermal growth factor receptor), cetuximab or panitumumab in first line.
The treatment and these modalities will be decided by the investigator.
The study is based on blood sampling, the frequency of which is described below, rhythm of plasma samples:
Inclusion after determination of wild status RAS tissues.
First sampling of 2 EDTA (ethylenediaminetetraacetic acid) tubes, then at each tumour evaluation during treatment with anti EGFR (epidermal growth facor receptor), every 4 cures. At the end of treatment or after more than 36 treatment cures, a final sample will be taken.
No results of the samples will be communicated to the investigator, the sponsor will centralize these results for the final analysis of the study.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Intplex test
- Keywords
- Metastatic Colorectal Cancer, Detection of the emergence of RAS mutations, Circulating DNA in patients, Treatment with anti-EGFR therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intplex testDevice
Blood sample at each tumor assessment
| Study group | Role | What they receive |
|---|---|---|
| Intplex test | Experimental | In vitro diagnostic device Receives: Device: Intplex test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with mCRC (metastatic colorectal cancer) who develop a RAS (rat sarcoma viral oncogene homolog) mutation under anti-EGFR (epidermal growth factor receptor) therapy
From baseline to the end of treatment
Measured: Approximately 8 weeks
Secondary outcomes (11)
Probability of obtaining a positive test, i.e. RAS status mutated by the Intplex® test, among the patients determined RAS mutated by the tissue test
From baseline to the end of treatment
Measured: Approximately 8 weeks
Probability of obtaining a negative test, i.e. wild RAS status by the Intplex® test among patients determined wild RAS by the tissue test
From baseline to the end of treatment
Measured: Approximately 8 weeks
Probability of obtaining a positive test, i.e. BRAF status mutated by the Intplex® test, among the patients determined BRAF mutated by the tissue test
From baseline to the end of treatment
Measured: Approximately 8 weeks
Probability of obtaining a negative test, i.e. wild BRAF status by Intplex® test among patients determined wild BRAF by tissue test.compared to the pre-treatment tissue test
From baseline to the end of treatment
Measured: Approximately 8 weeks
Proportion of patients with a BRAF mutation under anti-EGFR therapy
From baseline to the end of treatment
Measured: Approximately 8 weeks
Progression-free survival
From baseline to the database cutoff
Measured: Approximately 36 months
Global survival
From baseline to the database cutoff
Measured: Approximately 36 months
Evaluation of the following criterion: total concentration of circulating DNA
From baseline to the end of treatment
Measured: Approximately 8 weeks
Evaluation of the following criterion: integrity index
From baseline to the end of treatment
Measured: Approximately 8 weeks
Evaluation of the following criterion: concentration of mutated alleles
From baseline to the end of treatment
Measured: Approximately 8 weeks
Evaluation of the following criterion: frequency of mutated alleles
From baseline to the end of treatment
Measured: Approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start26 Jul 2018
- Primary completion3 Dec 2023
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- 130 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908788
- Sponsor's protocol ID
- 2018-A00232-53
- Acronym
- EmutRAS
- Status last verified
- Apr 2025
- First submitted
- 25 Jan 2019
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of the Emergence of RAS (Rat Sarcoma Viral Oncogene Homolog) Mutations in Circulating DNA (Deoxyribonucleic Acid) in Patients With Metastatic Colorectal Cancer During Treatment With Anti-EGFR (Epidermal Growth Factor Receptor) Therapy
- ClinicalTrials.gov ID
- NCT03908788
- Acronym / sponsor ID
- EmutRAS / 2018-A00232-53
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic Colorectal Cancer, Detection of the emergence of RAS mutations, Circulating DNA in patients, Treatment with anti-EGFR therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 3 Dec 2023 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 9 Apr 2019 (actual)
- 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.
The analysis of circulating DNA (Deoxyribonucleic acid) to identify potential resistance mechanisms during anti-EGFR (epidermal growth factor receptor) treatment is of great interest, as evidenced by the recent journal published by Corcoran in the prestigious New England Journal of Medicine.
EmutRAS is one of the first studies that will specifically and prospectively evaluate the RAS mutational switch and its impact on the efficiency of the 1st line processing.
Detailed description
The primary study objective is the Detection of RAS mutational (rat sarcoma viral oncogene homolog) "switch" in circulating DNA by Intplex® test in mCRC (metastatic colorectal cancer) patients treated with antibody anti-EGFR (epidermal growth factor receptor), cetuximab or panitumumab in first line.
The treatment and these modalities will be decided by the investigator.
The study is based on blood sampling, the frequency of which is described below, rhythm of plasma samples:
Inclusion after determination of wild status RAS tissues.
First sampling of 2 EDTA (ethylenediaminetetraacetic acid) tubes, then at each tumour evaluation during treatment with anti EGFR (epidermal growth facor receptor), every 4 cures. At the end of treatment or after more than 36 treatment cures, a final sample will be taken.
No results of the samples will be communicated to the investigator, the sponsor will centralize these results for the final analysis of the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intplex test | Experimental | Device: Intplex testIn vitro diagnostic device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with histologically confirmed metastatic colorectal cancer
- Patient treated in the first line by one of the treatments below and according to a bi-monthly schema for cetuximab: FOLFIRI (elvorin + 5 Fluorouracil + irinotecan) ou FOLFOX (elvorin + 5 Fluorouracil + oxalplatin) + Cetuximab* (Erbitux) ; FOLFIRI ou FOLFOX + Panitumumab (Vectibix); FOLFIRINOX ou FOLFOXIRI ((elvorin + 5 Fluorouracil + oxaliplatin + irinotecan) + Cetuximab* (Erbitux); FOLFIRINOX ou FOLFOXIRI + Panitumumab (Vectibix) For patient treated cetuximab administration will be bi-monthly
- Patient with at least one evaluable metastatic target according to RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)
- Wild RAS (rat sarcoma viral oncogene homolog) status detected by standard tissue test, on primary tumor and / or metastasis
- Wild BRAF (murine sarcoma viral oncogene homolog B) status detected by standard tissue test, on primary tumor and / or metastasis
Key exclusion criteria (10 listed)
- Previous treatment with an anti-EGFR (epidermal growth factor receptor)
- Patient with a multifocal primary tumor
- RAS (rat sarcoma viral oncogene homolog) status mutated or not detectable on tissue analysis
- BRAF (murine sarcoma viral oncogene homolog B) status mutated or undetectable on tissue analysis
- Patient receiving adjuvant chemotherapy or radiotherapy within <14 days
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 |
|---|---|---|
| Intplex testBlood sample at each tumor assessment | Device | Intplex test |
Primary outcome
Proportion of patients with mCRC (metastatic colorectal cancer) who develop a RAS (rat sarcoma viral oncogene homolog) mutation under anti-EGFR (epidermal growth factor receptor) therapy
Time frame: Approximately 8 weeks
From baseline to the end of treatment
11 secondary outcomes
Probability of obtaining a positive test, i.e. RAS status mutated by the Intplex® test, among the patients determined RAS mutated by the tissue test
Time frame: Approximately 8 weeks
Probability of obtaining a negative test, i.e. wild RAS status by the Intplex® test among patients determined wild RAS by the tissue test
Time frame: Approximately 8 weeks
Probability of obtaining a positive test, i.e. BRAF status mutated by the Intplex® test, among the patients determined BRAF mutated by the tissue test
Time frame: Approximately 8 weeks
Probability of obtaining a negative test, i.e. wild BRAF status by Intplex® test among patients determined wild BRAF by tissue test.compared to the pre-treatment tissue test
Time frame: Approximately 8 weeks
Proportion of patients with a BRAF mutation under anti-EGFR therapy
Time frame: Approximately 8 weeks
Progression-free survival
Time frame: Approximately 36 months
Global survival
Time frame: Approximately 36 months
Evaluation of the following criterion: total concentration of circulating DNA
Time frame: Approximately 8 weeks
Evaluation of the following criterion: integrity index
Time frame: Approximately 8 weeks
Evaluation of the following criterion: concentration of mutated alleles
Time frame: Approximately 8 weeks
Evaluation of the following criterion: frequency of mutated alleles
Time frame: Approximately 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intplex test in people with Metastatic Colorectal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of patients with mCRC (metastatic colorectal cancer) who develop a RAS (rat sarcoma viral oncogene homolog) mutation under anti-EGFR (epidermal growth factor receptor) therapy (time frame: Approximately 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2025.