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This study has been withdrawn prior to enrollment.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
  Purpose

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:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899535

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

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov 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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014