Lung CancerNCT00900328
Study of Tumor Samples From Patients With Lung Cancer
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology at 1 site in United States.
Trial summary
RATIONALE: Studying samples of tumor tissue 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 laboratory study is looking at tumor samples from patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- laboratory biomarker analysis
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-small cell lung adenocarcinoma enrolled on CALCB 140202
Who may be able to join
- Registration to Cancer and Leukemia Group B (CALGB) 140202
- Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
- Informed consent: the CALGB does not require that a separate consent form be signed for this study
- The subject population to be studied in this protocol includes patients selected from CALGB 140202; all such patients have signed a written informed consent document meeting all federal, state, and institutional guidelines as part of entry into that trial
- All samples to be studied were obtained and stored as part of CALGB 140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
- There should be no physical, psychological, social, or legal risks associated with this study; no invasive procedures are recommended or requested
- All appropriate and necessary procedures will be utilized to maintain confidentiality; all patients who have had samples submitted for analysis will have their CALGB study number used to identify specimens
- This study does not require direct patient contact and no specific risk or benefits to individuals involved in the trial are anticipated; it is likely, however, that the information gained will substantially help similar patients in the future
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Project to Study the Expression of c-MET and p53 in Resected Lung Adenocarcinoma Specimens
RATIONALE: Studying samples of tumor tissue 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 laboratory study is looking at tumor samples from patients with lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the correlation between c-Met expression, mutation and amplification, with stage and overall survival in patients with adenocarcinoma (AC) of the lung.
Secondary
- To determine the correlation with epithelial mesenchymal transition (EMT), EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, loss of heterozygosity (LOH), DUB3 expression \& regulation, and ALK translocation, with respect to survival.
- To determine the correlation with circulating c-Met and HGF in AC and evaluate prognostic implications of circulating markers in AC of lung.
- To determine (when available) levels of circulating Met and HGF in serum before and after surgery.
OUTLINE: This is a multicenter study.
Previously collected tissue samples from patients enrolled in CALGB 140202 are assessed for mutation analysis of c-Met, EGFR, and K-ras. DNA is examined by PCR, followed by agarose gel electrophoresis; gene amplification of c-Met is examined by real time quantitative PCR; met/HF protein in serum is examined by ELISA; and c-Met, EGFR, p53, c-CBL, DUB3 enzyme, and ALK, and epithelial mesenchymal transition examined by IHC.
- Conditions
- Lung Cancer
- Being tested
- laboratory biomarker analysis
- Keywords
- adenocarcinoma of the lung, recurrent non-small cell lung cancer, stage 0 non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative Studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (biomarkers in resected AC specimens) | Previously collected tissue samples from patients enrolled in CALGB 140202 are assessed for mutation analysis of c-Met, EGFR, Kras, p53, and c-CBL via standard PCR and sequencing; gene amplification of c-Met via real time quantitative PCR; LOH analysis of c-CBL; expression levels of met/HGF protein in serum via ELISA; and expression levels of c-Met, EGFR, p53, c-CBL, DUB3, ALK, and EMT via IHC. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
c-Met expression
The correlation of c-Met expression and stage will be tested using Fisher's exact test. The proportions of c-Met overexpressed in stage I and stage II or higher will be estimated as well as the confidence intervals. The correlation of c-Met expression and survival will be tested using log rank test. The hazard ratio and its confidence interval will be estimated using a Cox model with a single predictor. Summary statistics will be provided for all c-Met measures.
Measured: Baseline
Secondary outcomes (8)
EMT expression
The correlation of EMT, EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, and LOH, DUB3 expression, and ALK translocation, circulating c-Met and HGF with respect to survival will be evaluated by Cox model with these markers as continuous predictors or by log rank test with these biomarkers dichotomized at certain cutoff points, such as median or ad hoc optimal cutoff points.
Measured: Baseline
Mutations in EGFR, Kras, p53, and c-CBL
The correlation of EMT, EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, and LOH, DUB3 expression, and ALK translocation, circulating c-Met and HGF with respect to survival will be evaluated by Cox model with these markers as continuous predictors or by log rank test with these biomarkers dichotomized at certain cutoff points, such as median or ad hoc optimal cutoff points.
Measured: Baseline
c-CBL expression and LOH
The correlation of EMT, EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, and LOH, DUB3 expression, and ALK translocation, circulating c-Met and HGF with respect to survival will be evaluated by Cox model with these markers as continuous predictors or by log rank test with these biomarkers dichotomized at certain cutoff points, such as median or ad hoc optimal cutoff points.
Measured: Baseline
DUB3 expression and regulation
The correlation of EMT, EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, and LOH, DUB3 expression, and ALK translocation, circulating c-Met and HGF with respect to survival will be evaluated by Cox model with these markers as continuous predictors or by log rank test with these biomarkers dichotomized at certain cutoff points, such as median or ad hoc optimal cutoff points.
Measured: Baseline
ALK Translocation
The correlation of EMT, EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, and LOH, DUB3 expression, and ALK translocation, circulating c-Met and HGF with respect to survival will be evaluated by Cox model with these markers as continuous predictors or by log rank test with these biomarkers dichotomized at certain cutoff points, such as median or ad hoc optimal cutoff points.
Measured: Baseline
Circulating c-Met and HGF in AC
The correlation of EMT, EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, and LOH, DUB3 expression, and ALK translocation, circulating c-Met and HGF with respect to survival will be evaluated by Cox model with these markers as continuous predictors or by log rank test with these biomarkers dichotomized at certain cutoff points, such as median or ad hoc optimal cutoff points.
Measured: Baseline
Prognostic implications of circulating markers in AC of lung
Measured: Baseline
Levels of circulating Met and HGF in serum before and after surgery (when available)
Measured: At time of surgery
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 startSep 2008
- Primary completionFeb 2012
- Study completionSep 2012
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 Alliance for Clinical Trials in OncologyThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ravi Salgia, MD, PhD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900328
- Sponsor's protocol ID
- CALGB-150607
- Other IDs
- CDR0000614602, NCI-2009-00451, U10CA180821
- Status last verified
- Aug 2017
- First submitted
- 9 May 2009
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Project to Study the Expression of c-MET and p53 in Resected Lung Adenocarcinoma Specimens
- ClinicalTrials.gov ID
- NCT00900328
- Acronym / sponsor ID
- CALGB-150607
- Conditions
- Lung Cancer
- Keywords
- adenocarcinoma of the lung, recurrent non-small cell lung cancer, stage 0 non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA 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
- 280 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Sep 2012 (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: Studying samples of tumor tissue 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 laboratory study is looking at tumor samples from patients with lung cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the correlation between c-Met expression, mutation and amplification, with stage and overall survival in patients with adenocarcinoma (AC) of the lung.
Secondary
- To determine the correlation with epithelial mesenchymal transition (EMT), EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, loss of heterozygosity (LOH), DUB3 expression \& regulation, and ALK translocation, with respect to survival.
- To determine the correlation with circulating c-Met and HGF in AC and evaluate prognostic implications of circulating markers in AC of lung.
- To determine (when available) levels of circulating Met and HGF in serum before and after surgery.
OUTLINE: This is a multicenter study.
Previously collected tissue samples from patients enrolled in CALGB 140202 are assessed for mutation analysis of c-Met, EGFR, and K-ras. DNA is examined by PCR, followed by agarose gel electrophoresis; gene amplification of c-Met is examined by real time quantitative PCR; met/HF protein in serum is examined by ELISA; and c-Met, EGFR, p53, c-CBL, DUB3 enzyme, and ALK, and epithelial mesenchymal transition examined by IHC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (biomarkers in resected AC specimens) | – | Other: laboratory biomarker analysisPreviously collected tissue samples from patients enrolled in CALGB 140202 are assessed for mutation analysis of c-Met, EGFR, Kras, p53, and c-CBL via standard PCR and sequencing; gene amplification of c-Met via real time quantitative PCR; LOH analysis of c-CBL; expression levels of met/HGF protein in serum via ELISA; and expression levels of c-Met, EGFR, p53, c-CBL, DUB3, ALK, and EMT via IHC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-small cell lung adenocarcinoma enrolled on CALCB 140202
Key inclusion criteria (8 listed)
- Registration to Cancer and Leukemia Group B (CALGB) 140202
- Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
- Informed consent: the CALGB does not require that a separate consent form be signed for this study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| laboratory biomarker analysisCorrelative Studies | Other | Ancillary-Correlative (biomarkers in resected AC specimens) |
Primary outcome
c-Met expression
Time frame: Baseline
The correlation of c-Met expression and stage will be tested using Fisher's exact test. The proportions of c-Met overexpressed in stage I and stage II or higher will be estimated as well as the confidence intervals. The correlation of c-Met expression and survival will be tested using log rank test. The hazard ratio and its confidence interval will be estimated using a Cox model with a single predictor. Summary statistics will be provided for all c-Met measures.
8 secondary outcomes
EMT expression
Time frame: Baseline
Mutations in EGFR, Kras, p53, and c-CBL
Time frame: Baseline
c-CBL expression and LOH
Time frame: Baseline
DUB3 expression and regulation
Time frame: Baseline
ALK Translocation
Time frame: Baseline
Circulating c-Met and HGF in AC
Time frame: Baseline
Prognostic implications of circulating markers in AC of lung
Time frame: Baseline
Levels of circulating Met and HGF in serum before and after surgery (when available)
Time frame: At time of surgery
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 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.
Ravi Salgia, MD, PhD study chair
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology at 1 site in United States.
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 0 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 2017. 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 United States. 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?
c-Met expression (time frame: Baseline). 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 2017.