Lung CancerNCT01124669
Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate
An observational study of Lung Cancer, run by ECOG-ACRIN Cancer Research Group.
Trial summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- DNA analysis, mutation analysis and laboratory biomarker analysis
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 13 Jun 2010to 13 Jul 2010
- Phase
- Observational
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Samples submitted for research from patients enrolled on E2501
DISEASE CHARACTERISTICS:
- Diagnosis of refractory non-small cell lung cancer
- Received sorafenib tosylate on protocol ECOG-E2501
- Available blood specimens
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: BRAF, KRAS and EGFR Mutation Detection in Non-Small Cell Lung Cancer Patients Treated With Sorafenib Monotherapy
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.
Read the detailed description
OBJECTIVES:
- To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501.
- To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen.
OUTLINE: This is a multicenter study.
DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.
- Conditions
- Lung Cancer
- Being tested
- DNA analysis, mutation analysis, laboratory biomarker analysis
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
mutation analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutation rate of sorafenib tosylate-target gene BRAF, and its upstream proteins KRAS and EGFR
Measured: 1 mont
Association between BRAF, KRAS, and EGFR mutation status and clinical benefits (stable disease or partial response)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study start13 Jun 2010
- Primary completion13 Jul 2010
- Study completion13 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christine Chung, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124669
- Sponsor's protocol ID
- CDR0000670998
- Other IDs
- ECOG-E2501T2
- Status last verified
- May 2017
- First submitted
- 14 May 2010
- Last updated
- 17 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAF, KRAS and EGFR Mutation Detection in Non-Small Cell Lung Cancer Patients Treated With Sorafenib Monotherapy
- ClinicalTrials.gov ID
- NCT01124669
- Acronym / sponsor ID
- CDR0000670998
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Jun 2010 (actual)
- Primary completion
- 13 Jul 2010 (actual)
- Study completion
- 13 Jul 2010 (actual)
- First posted
- 17 May 2010 (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.
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.
Detailed description
OBJECTIVES:
- To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501.
- To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen.
OUTLINE: This is a multicenter study.
DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Samples submitted for research from patients enrolled on E2501
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 |
|---|---|---|
| DNA analysis | Genetic | – |
| mutation analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Mutation rate of sorafenib tosylate-target gene BRAF, and its upstream proteins KRAS and EGFR
Time frame: 1 mont
Association between BRAF, KRAS, and EGFR mutation status and clinical benefits (stable disease or partial response)
Time frame: 1 month
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 17 May 2017.
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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.
Christine Chung, MD principal investigator
Vanderbilt-Ingram Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by ECOG-ACRIN Cancer Research Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Mutation rate of sorafenib tosylate-target gene BRAF, and its upstream proteins KRAS and EGFR (time frame: 1 mont). The study lists 2 primary outcomes in all. 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 17 May 2017.