Lung CancerNCT00990873
Study of Tissue Samples From Patients With Stage I Non-Small Cell Lung Cancer Enrolled on Research Study CALGB-140202
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology.
Trial summary
RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. 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?
- gene expression analysis, microarray analysis and reverse transcriptase-polymerase chain reaction
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Nov 2014
- 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 diagnosed with stage I non-small cell lung cancer and previously enrolled on CALGB 140202.
- Registration to CALGB 140202
- Institutional Review Board (IRB) review and approval at the institutions 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.
About this study
Official title: A Validation of the 64-Gene Signature Using Affymetrix-HG_U133A Array in Stage I NSCLC From the CALGB Lung Cancer Study (140202)
RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at tissue samples from patients with stage I non-small cell lung cancer enrolled on research study CALGB-140202.
Read the detailed description
OBJECTIVES:
- Determine whether the 64-gene signature can accurately predict the prognosis for survival of patients with stage I non-small cell lung cancer (NSCLC).
OUTLINE: RNA is purified from tissue samples obtained by the CALGB Lung Cancer Study (CALGB-140202). The RNA samples are used for gene expression analysis using the 64-gene signature and an Affymetrix-HG_U133A array. Reverse-transcriptase PCR may also be performed on selected samples.
- Conditions
- Lung Cancer
- Being tested
- gene expression analysis, microarray analysis, reverse transcriptase-polymerase chain reaction, laboratory biomarker analysis
- Keywords
- stage I 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
microarray analysisGenetic
reverse transcriptase-polymerase chain reactionGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival, defined as the time from surgery to death of any cause
Measured: Up to 5 years
Secondary outcomes (1)
Disease-free survival, defined as time from surgery to any recurrence (local or regional), second primary tumor, distant metastasis, or death of any cause
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2014
- Study completionNov 2014
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 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
- Ming You, MD, Study chair, Washington University Siteman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990873
- Sponsor's protocol ID
- CALGB-150803
- Other IDs
- CALGB-150803, CDR0000649826
- Status last verified
- Jun 2016
- First submitted
- 6 Oct 2009
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation of the 64-Gene Signature Using Affymetrix-HG_U133A Array in Stage I NSCLC From the CALGB Lung Cancer Study (140202)
- ClinicalTrials.gov ID
- NCT00990873
- Acronym / sponsor ID
- CALGB-150803
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Oct 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 the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at tissue samples from patients with stage I non-small cell lung cancer enrolled on research study CALGB-140202.
Detailed description
OBJECTIVES:
- Determine whether the 64-gene signature can accurately predict the prognosis for survival of patients with stage I non-small cell lung cancer (NSCLC).
OUTLINE: RNA is purified from tissue samples obtained by the CALGB Lung Cancer Study (CALGB-140202). The RNA samples are used for gene expression analysis using the 64-gene signature and an Affymetrix-HG_U133A array. Reverse-transcriptase PCR may also be performed on selected samples.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with stage I non-small cell lung cancer and previously enrolled on CALGB 140202.
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 | – |
| microarray analysis | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Overall survival, defined as the time from surgery to death of any cause
Time frame: Up to 5 years
1 secondary outcome
Disease-free survival, defined as time from surgery to any recurrence (local or regional), second primary tumor, distant metastasis, or death of any cause
Time frame: Up to 5 years
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 28 Jun 2016.
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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.
Ming You, MD study chair
Washington University Siteman Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology.
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 28 Jun 2016. 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?
Overall survival, defined as the time from surgery to death of any cause (time frame: Up to 5 years). 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 28 Jun 2016.