Lung CancerNCT01414595
Study of Tissue Samples From Patients With Non-Small Cell Lung Cancer
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology at 11 sites in United States.
Trial summary
RATIONALE: Studying samples of 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 research trial studies tissue samples from patients with non-small cell 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?
- DNA analysis, DNA methylation analysis and RNA analysis
- How many people
- 248 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2012to Feb 2017
- 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 lung cancer who are registered to CALGB-140202.
- Patient must have been registered to CALGB 140202.
- Tumor histology should be either primary adenocarcinoma or squamous cell carcinoma of the lung.
- Patients are eligible for this study if their samples from CALGB 140202 are available.
- All living patients must sign the CALGB 151107 consent form to be eligible for this trial.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Duke Cancer Institute
Durham, North Carolina, 27710
Union Hospital of Cecil County
Elkton, Maryland, 21921
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, 19958
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, 90048
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, 02903
Miriam Hospital
Providence, Rhode Island, 02906
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
About this study
Official title: Molecular Characterization of Lung Cancer: A Collaboration With the Cancer Genome Atlas Project (TGCA)
RATIONALE: Studying samples of 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 research trial studies tissue samples from patients with non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- To identify and characterize single nucleotide variations (SNVs) in non-small cell lung cancer (NSCLC) specimens.
- To identify and characterize structural variations in the genomes of NSCLC specimens.
- To identify and characterize other genomic alterations including, but not limited to, expression profiling and methylation.
OUTLINE: DNA and RNA extracted from archived specimens are analyzed for single nucleotide variations, structural variations in the genomes, and other genomic alterations including, but not limited to, gene expression profiling and methylation. Clinical data related to disease, treatment, and recurrence from each patient sample is also collected.
- Conditions
- Lung Cancer
- Being tested
- DNA analysis, DNA methylation analysis, RNA analysis, gene expression analysis, polymorphism analysis
- Keywords
- adenocarcinoma of the lung, adenosquamous cell lung cancer, non-small cell lung cancer, squamous 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.
DNA analysisGenetic
DNA methylation analysisGenetic
RNA analysisGenetic
gene expression analysisGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
medical chart reviewOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | CALGB 140202 outlines the standard procedures for sample procurement. Samples to be used for this project have already been obtained and are currently banked at the CALGB Pathology Coordinating Office (PCO) and the Lung Cancer Tissue Bank at Brigham and Women's Hospital. Receives: Genetic: DNA analysis; Genetic: DNA methylation analysis; Genetic: RNA analysis; Genetic: gene expression analysis; Genetic: polymorphism analysis; Other: laboratory biomarker analysis; Other: medical chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and characterization of SNVs in primary adenocarcinoma of the lung or squamous cell carcinoma of the lung
Measured: up to 5 years
Identification and characterization of structural variations in the genomes of NSCLC
Measured: up to 5 years
Identification and characterization of other genomic alterations including, but not limited to, gene expression profiling and methylation
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 posted11 Aug 2011 (estimated)
- Study startMar 2012
- Primary completionFeb 2017
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
- 248 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
- Ramaswamy Govindan, MD, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414595
- Sponsor's protocol ID
- CALGB-151107
- Other IDs
- CALGB-151107, CDR0000706375
- Status last verified
- Jun 2017
- First submitted
- 10 Aug 2011
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterization of Lung Cancer: A Collaboration With the Cancer Genome Atlas Project (TGCA)
- ClinicalTrials.gov ID
- NCT01414595
- Acronym / sponsor ID
- CALGB-151107
- Conditions
- Lung Cancer
- Keywords
- adenocarcinoma of the lung, adenosquamous cell lung cancer, non-small cell lung cancer, squamous cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2012
- Primary completion
- Feb 2017 (actual)
- First posted
- 11 Aug 2011 (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 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 research trial studies tissue samples from patients with non-small cell lung cancer.
Detailed description
OBJECTIVES:
- To identify and characterize single nucleotide variations (SNVs) in non-small cell lung cancer (NSCLC) specimens.
- To identify and characterize structural variations in the genomes of NSCLC specimens.
- To identify and characterize other genomic alterations including, but not limited to, expression profiling and methylation.
OUTLINE: DNA and RNA extracted from archived specimens are analyzed for single nucleotide variations, structural variations in the genomes, and other genomic alterations including, but not limited to, gene expression profiling and methylation. Clinical data related to disease, treatment, and recurrence from each patient sample is also collected.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: DNA analysis, Genetic: DNA methylation analysis, Genetic: RNA analysis, Genetic: gene expression analysis, Genetic: polymorphism analysis, Other: laboratory biomarker analysis, Other: medical chart reviewCALGB 140202 outlines the standard procedures for sample procurement. Samples to be used for this project have already been obtained and are currently banked at the CALGB Pathology Coordinating Office (PCO) and the Lung Cancer Tissue Bank at Brigham and Women's Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with lung cancer who are registered to 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 |
|---|---|---|
| DNA analysis | Genetic | Group 1 |
| DNA methylation analysis | Genetic | Group 1 |
| RNA analysis | Genetic | Group 1 |
| gene expression analysis | Genetic | Group 1 |
| polymorphism analysis | Genetic | Group 1 |
| laboratory biomarker analysis | Other | Group 1 |
| medical chart review | Other | Group 1 |
Primary outcome
Identification and characterization of SNVs in primary adenocarcinoma of the lung or squamous cell carcinoma of the lung
Time frame: up to 5 years
Identification and characterization of structural variations in the genomes of NSCLC
Time frame: up to 5 years
Identification and characterization of other genomic alterations including, but not limited to, gene expression profiling and methylation
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 27 Jun 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.
Ramaswamy Govindan, MD study chair
Washington University School of Medicine
11 sites 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 11 sites 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?
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 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Identification and characterization of SNVs in primary adenocarcinoma of the lung or squamous cell carcinoma of the lung (time frame: up to 5 years). The study lists 3 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 27 Jun 2017.