Metastatic Colorectal CancerCircuLOR-1NCT02827565
Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer
A study testing KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA in people with Metastatic Colorectal Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
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 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?
- KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2016to 19 Jan 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
- 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
Who cannot join
- Patients whose health-cons indicates a blood sample 10mL
- Age < 18 years
- Pregnant or breast feeding females
- Persons deprived of liberty or under supervision
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA
- Keywords
- colorectal cancer, Kras mutation, Nras mutation, Braf mutation
- Medical subject headings
- Colorectal Neoplasms
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 DNAOther
Also called NGS
10 ml blood sample
| Study group | Role | What they receive |
|---|---|---|
| CircuLOR-1 | Experimental | KRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAF (exon 15) mutations Receives: Other: 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.
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.
Measured: 1 day
Secondary outcomes (1)
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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start3 Feb 2016
- Primary completion5 Jan 2017
- Study completion19 Jan 2017
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GAVOILLE CELINE, MD, Principal investigator, Institut de Cancérologie de LorraineHARLE ALEXANDRE, Study chair, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827565
- Sponsor's protocol ID
- 2015-A00922-47
- Acronym
- CircuLOR-1
- Status last verified
- Aug 2018
- First submitted
- 6 Jul 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02827565
- Acronym / sponsor ID
- CircuLOR-1 / 2015-A00922-47
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- colorectal cancer, Kras mutation, Nras mutation, Braf mutation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 11 Jul 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.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CircuLOR-1 | Experimental | Other: KRAS, NRAS et BRAF mutation analysis from circulating plasma DNAKRAS (exons 2, 3 et 4), NRAS (exons 2, 3 et 4) and BRAF (exon 15) mutations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Patients whose health-cons indicates a blood sample 10mL
- Age < 18 years
- Pregnant or breast feeding females
- Persons deprived of liberty or under supervision
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: NGS10 ml blood sample | Other | CircuLOR-1 |
Primary outcome
Technical Optimization of KRAS, BRAF and NRAS mutations detection
Time frame: 1 day
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 secondary outcome
KRAS, NRAS et BRAF mutational status
Time frame: 1 day
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 8 Aug 2018.
- Individual participant dataSharing planned: No
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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.
GAVOILLE CELINE, MD principal investigator
Institut de Cancérologie de Lorraine
HARLE ALEXANDRE study chair
Institut de Cancérologie de Lorraine
1 site 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 Metastatic Colorectal Cancer, run by Institut de Cancérologie de Lorraine at 1 site 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 4 inclusion and 4 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 8 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 1 site 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?
Technical Optimization of KRAS, BRAF and NRAS mutations detection (time frame: 1 day). 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 8 Aug 2018.