Cancer Genome Study Using Samples From Patients With Stage I or Stage II Non-Small Cell Lung Cancer Treated on Clinical Trial ACOSOG-Z0030

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00899535
First received: May 9, 2009
Last updated: September 17, 2013
Last verified: September 2013

May 9, 2009
September 17, 2013
October 2008
October 2010   (final data collection date for primary outcome measure)
Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00899535 on ClinicalTrials.gov Archive Site
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Cancer Genome Study Using Samples From Patients With Stage I or Stage II Non-Small Cell Lung Cancer Treated on Clinical Trial ACOSOG-Z0030
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.

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.

Observational
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Lung Cancer
  • Genetic: DNA analysis
  • Genetic: RNA analysis
  • Genetic: microarray analysis
  • Genetic: mutation analysis
  • Genetic: polymorphism analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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October 2010   (final data collection date for primary outcome measure)

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

PATIENT CHARACTERISTICS:

  • Not Specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00899535
CDR0000617514, ACOSOG-Z4082
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Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Mark S. Allen, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP