Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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

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.

Condition Intervention
Lung Cancer
Genetic: DNA analysis
Genetic: RNA analysis
Genetic: microarray analysis
Genetic: mutation analysis
Genetic: polymorphism analysis

Study Type: Observational
Official Title: The Cancer Genome Atlas (TCGA) Utilizing Z0030 NSCLC Patient Samples

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2008
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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


  • Not Specified


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00899535

Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Study Chair: Mark S. Allen, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00899535     History of Changes
Other Study ID Numbers: CDR0000617514, ACOSOG-Z4082
Study First Received: May 9, 2009
Last Updated: September 17, 2013
Health Authority: Unspecified

Keywords provided by Alliance for Clinical Trials in Oncology:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on March 01, 2015