Lung CancerNCT00899535
Cancer Genome Study Using Samples From Patients With Stage I or Stage II Non-Small Cell Lung Cancer Treated on Clinical Trial ACOSOG-Z0030
An observational study of Lung Cancer, run by Alliance for Clinical Trials in Oncology.
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. 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, RNA analysis and microarray analysis
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Feb 2013
- 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 non-small cell carcinoma previously registered on ACOSOG-Z0030.
DISEASE CHARACTERISTICS:
- Diagnosis of non-small cell carcinoma
- Primary, untreated disease
- Stage I or II (T1 or T2, N0 or non-hilar N1, M0) disease
- Any of the following histologies allowed:
- Squamous cell carcinoma
- Adenocarcinoma (< 10%)
- Large cell carcinoma (high-grade)
- Available tumor tissue samples collected on clinical trial ACOSOG-Z0030 and meeting the following criteria:
- Snap-frozen and stored at a temperature of -80°C or lower
- Specimens may come from any site within the lung or one that is involved by direct regional extension of tumor from the originating site in the lung
- No regional lymph node or distant metastases
- No recurrent or persistent disease after prior neoadjuvant or adjuvant treatment for lung cancer
- Must have matching frozen samples of normal tissue and blood
About this study
Official title: The Cancer Genome Atlas (TCGA) Utilizing Z0030 NSCLC Patient Samples
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 research study is looking at the cancer genome using tumor samples from patients with stage I or stage II non-small cell lung cancer treated on clinical trial ACOSOG-Z0030.
Read the detailed description
OBJECTIVES:
- To investigate the clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens from patients with stage I or II, N0 or N1 (less than hilar) non-small cell lung cancer.
OUTLINE: This is a multicenter study.
Biological specimens are collected from participating clinical sites and analyzed by transcription profiling of RNA and microRNA; detection of DNA copy number changes and chromosomal rearrangements; epigenetic modifications analyses; and sequencing of genomic segments, genes, and regulatory regions to assess sequence variation. Clinical information associated with each specimen donor is also collected.
- Conditions
- Lung Cancer
- Being tested
- DNA analysis, RNA analysis, microarray analysis, mutation analysis, polymorphism analysis
- Keywords
- adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, stage I non-small cell lung cancer, stage II 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.
DNA analysisGenetic
RNA analysisGenetic
microarray analysisGenetic
mutation analysisGenetic
polymorphism analysisGenetic
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | This research study is looking at the cancer genome using tumor samples from patients with stage I or stage II non-small cell lung cancer treated on clinical trial ACOSOG-Z0030. 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. Receives: Genetic: DNA analysis; Genetic: RNA analysis; Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymorphism analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens
Measured: Up to 3 years
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 startOct 2008
- Primary completionOct 2010
- Study completionFeb 2013
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
- Prospective
- Enrolment
- 70 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
- Mark Allen, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899535
- Sponsor's protocol ID
- ACOSOG-Z4082
- Other IDs
- ACOSOG-Z4082, CDR0000617514
- Status last verified
- Jun 2016
- First submitted
- 9 May 2009
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cancer Genome Atlas (TCGA) Utilizing Z0030 NSCLC Patient Samples
- ClinicalTrials.gov ID
- NCT00899535
- Acronym / sponsor ID
- ACOSOG-Z4082
- Conditions
- Lung Cancer
- Keywords
- adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Feb 2013 (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 research study is looking at the cancer genome using tumor samples from patients with stage I or stage II non-small cell lung cancer treated on clinical trial ACOSOG-Z0030.
Detailed description
OBJECTIVES:
- To investigate the clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens from patients with stage I or II, N0 or N1 (less than hilar) non-small cell lung cancer.
OUTLINE: This is a multicenter study.
Biological specimens are collected from participating clinical sites and analyzed by transcription profiling of RNA and microRNA; detection of DNA copy number changes and chromosomal rearrangements; epigenetic modifications analyses; and sequencing of genomic segments, genes, and regulatory regions to assess sequence variation. Clinical information associated with each specimen donor is also collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: DNA analysis, Genetic: RNA analysis, Genetic: microarray analysis, Genetic: mutation analysis, Genetic: polymorphism analysisThis research study is looking at the cancer genome using tumor samples from patients with stage I or stage II non-small cell lung cancer treated on clinical trial ACOSOG-Z0030. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with non-small cell carcinoma previously registered on ACOSOG-Z0030.
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 |
| RNA analysis | Genetic | Group 1 |
| microarray analysis | Genetic | Group 1 |
| mutation analysis | Genetic | Group 1 |
| polymorphism analysis | Genetic | Group 1 |
Primary outcome
Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens
Time frame: Up to 3 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 29 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.
Mark Allen, MD study chair
Mayo Clinic
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 29 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?
Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens (time frame: Up to 3 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 29 Jun 2016.