Lung CancerNCT01123460
Biomarkers Predicting Response in Patients With Non-Small Cell Lung Cancer Previously Treated With Erlotinib Hydrochloride
An observational study of Lung Cancer, run by ECOG-ACRIN Cancer Research Group.
Trial summary
RATIONALE: Studying samples of blood in the laboratory from patients receiving erlotinib hydrochloride may help doctors learn more about the effects of erlotinib hydrochloride on cells. It may also help doctors understand how well patients respond to treatment. 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?
- enzyme-linked immunosorbent assay and laboratory biomarker analysis
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2010to 12 Jun 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 E3503
DISEASE CHARACTERISTICS:
- Diagnosis of non-small cell lung cancer
- Received erlotinib hydrochloride on clinical trial ECOG-E3503
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Measurement of Potential Biomarkers Predicting Erlotinib Response
RATIONALE: Studying samples of blood in the laboratory from patients receiving erlotinib hydrochloride may help doctors learn more about the effects of erlotinib hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
PURPOSE: This research study is studying biomarkers predicting response in patients with non-small cell lung cancer previously treated with erlotinib hydrochloride.
Read the detailed description
OBJECTIVES:
- To evaluate whether serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin can be utilized as biomarkers to predict response in patients with non-small cell lung cancer treated with erlotinib hydrochloride.
OUTLINE: Serum samples are analyzed for NGAL, MMP-9, NGAL/MMP-9, and soluble E-cadherin by ELISA and Luminex assays.
- Conditions
- Lung Cancer
- Being tested
- enzyme-linked immunosorbent assay, laboratory biomarker analysis
- Keywords
- 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.
enzyme-linked immunosorbent assayOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin levels as predictors of erlotinib hydrochloride 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 posted14 May 2010 (estimated)
- Study start12 Apr 2010
- Primary completion12 Jun 2010
- Study completion12 Jun 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
- 127 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
- Steven M. Dubinett, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123460
- Sponsor's protocol ID
- CDR0000670992
- Other IDs
- ECOG-E3503T2
- Status last verified
- May 2017
- First submitted
- 13 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
- Measurement of Potential Biomarkers Predicting Erlotinib Response
- ClinicalTrials.gov ID
- NCT01123460
- Acronym / sponsor ID
- CDR0000670992
- Conditions
- Lung Cancer
- Keywords
- non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Apr 2010 (actual)
- Primary completion
- 12 Jun 2010 (actual)
- Study completion
- 12 Jun 2010 (actual)
- First posted
- 14 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 in the laboratory from patients receiving erlotinib hydrochloride may help doctors learn more about the effects of erlotinib hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
PURPOSE: This research study is studying biomarkers predicting response in patients with non-small cell lung cancer previously treated with erlotinib hydrochloride.
Detailed description
OBJECTIVES:
- To evaluate whether serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin can be utilized as biomarkers to predict response in patients with non-small cell lung cancer treated with erlotinib hydrochloride.
OUTLINE: Serum samples are analyzed for NGAL, MMP-9, NGAL/MMP-9, and soluble E-cadherin by ELISA and Luminex assays.
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 E3503
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 |
|---|---|---|
| enzyme-linked immunosorbent assay | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Baseline serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin levels as predictors of erlotinib hydrochloride 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.
Steven M. Dubinett, MD principal investigator
Jonsson Comprehensive 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?
Baseline serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin levels as predictors of erlotinib hydrochloride response (time frame: 1 month). 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.