Lung CancerNCT00896909
HER-2 Mutations in Tumor Samples From Patients With Advanced Non-Small Cell Lung Cancer Treated on Clinical Trial ECOG-2598
An observational study of Lung Cancer, run by ECOG-ACRIN Cancer Research Group.
Trial summary
RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may 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?
- gene expression analysis, mutation analysis and polymerase chain reaction
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2006to 2 Jul 2006
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of non-small cell lung cancer meeting ≥ 1 of the following criteria:
- Recurrent disease
- Stage IIIB with pleural or pericardial effusion
- Stage IV disease
- Treated on protocol ECOG-2598
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Evaluation of HER2 Mutations in Patient Tumors From E2598
RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at HER-2 mutations in tumor samples from patients with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial ECOG-2598.
Read the detailed description
OBJECTIVES:
- Correlate clinical response to trastuzumab (Herceptin®) with the presence of mutation in the HER-2 kinase domain in tumor samples from patients with advanced non-small cell lung cancer treated on protocol ECOG-2598.
- Correlate mutations with time to progression and survival of these patients.
OUTLINE: This is a multicenter study.
Tissue specimens are analyzed by polymerase chain reaction to assess mutations in the HER-2 gene. Laboratory/biomarker analysis data is correlated with clinical data from protocol ECOG-2598.
PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- gene expression analysis, mutation analysis, polymerase chain reaction, diagnostic 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.
gene expression analysisGenetic
mutation analysisGenetic
polymerase chain reactionGenetic
diagnostic laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of HER-2 mutation with response, time to progression, and survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start2 Feb 2006
- Primary completion2 Jul 2006
- Study completion2 Jul 2006
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
- 44 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
- David P. Carbone, MD, PhD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896909
- Sponsor's protocol ID
- CDR0000476582
- Other IDs
- ECOG-E2598T1
- Status last verified
- May 2017
- First submitted
- 9 May 2009
- 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
- Evaluation of HER2 Mutations in Patient Tumors From E2598
- ClinicalTrials.gov ID
- NCT00896909
- Acronym / sponsor ID
- CDR0000476582
- 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
- 44 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Feb 2006 (actual)
- Primary completion
- 2 Jul 2006 (actual)
- Study completion
- 2 Jul 2006 (actual)
- First posted
- 12 May 2009 (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: Collecting samples of tumor tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at HER-2 mutations in tumor samples from patients with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial ECOG-2598.
Detailed description
OBJECTIVES:
- Correlate clinical response to trastuzumab (Herceptin®) with the presence of mutation in the HER-2 kinase domain in tumor samples from patients with advanced non-small cell lung cancer treated on protocol ECOG-2598.
- Correlate mutations with time to progression and survival of these patients.
OUTLINE: This is a multicenter study.
Tissue specimens are analyzed by polymerase chain reaction to assess mutations in the HER-2 gene. Laboratory/biomarker analysis data is correlated with clinical data from protocol ECOG-2598.
PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.
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
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 |
|---|---|---|
| gene expression analysis | Genetic | – |
| mutation analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| diagnostic laboratory biomarker analysis | Other | – |
Primary outcome
Correlation of HER-2 mutation with response, time to progression, and survival
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.
David P. Carbone, MD, PhD study chair
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?
Correlation of HER-2 mutation with response, time to progression, and survival. 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.