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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
  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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Tumor samples from patients enrolled on Z0030.

Enrollment: 70
Study Start Date: October 2008
Study Completion Date: February 2013
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Genetic: DNA analysis Genetic: RNA analysis Genetic: microarray analysis Genetic: mutation analysis Genetic: polymorphism analysis

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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with non-small cell carcinoma previously registered on ACOSOG-Z0030.
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
  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 ClinicalTrials.gov identifier: NCT00899535

Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Mark Allen, MD Mayo Clinic
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00899535     History of Changes
Other Study ID Numbers: ACOSOG-Z4082  CDR0000617514 
Study First Received: May 9, 2009
Last Updated: June 27, 2016
Health Authority: United States: Institutional Review Board

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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on December 05, 2016