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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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00899535
First received: May 9, 2009
Last updated: June 27, 2016
Last verified: June 2016

May 9, 2009
June 27, 2016
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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens [ Designated as safety issue: No ]
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Tumor samples from patients enrolled on Z0030.
Non-Probability Sample
Patients diagnosed with non-small cell carcinoma previously registered on ACOSOG-Z0030.
Lung Cancer
  • Genetic: DNA analysis
  • Genetic: RNA analysis
  • Genetic: microarray analysis
  • Genetic: mutation analysis
  • Genetic: polymorphism analysis
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.
Interventions:
  • Genetic: DNA analysis
  • Genetic: RNA analysis
  • Genetic: microarray analysis
  • Genetic: mutation analysis
  • Genetic: polymorphism analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
February 2013
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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00899535
ACOSOG-Z4082, ACOSOG-Z4082, CDR0000617514
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Mark Allen, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
June 2016

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