NCT Number: NCT00899535
Cancer Genome Study Using Samples From Patients With Stage I or Stage II Non-Small Cell Lung Cancer Treated on Clinical Trial ACOSOG-Z0030
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
RNA analysis
Geneticmicroarray analysis
Geneticmutation analysis
Geneticpolymorphism analysis
GeneticPrimary outcomes
-
Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens
Time frame: Up to 3 years
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
The Cancer Genome Atlas (TCGA) Utilizing Z0030 NSCLC Patient Samples
Important dates
- Study start
- 2008
- Primary completion
- 2010
- Study completion
- 2013
- First posted
- May 12, 2009
- Registry last updated
- Jun 29, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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