Skip to main content
OpenTrials
Completed

NCT Number: NCT00899535

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNA analysis

Genetic

RNA analysis

Genetic

microarray analysis

Genetic

mutation analysis

Genetic

polymorphism analysis

Genetic

Primary outcomes

  1. Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Cancer Genome Atlas (TCGA) Utilizing Z0030 NSCLC Patient Samples

Important dates

Study start
2008
Primary completion
2010
Study completion
2013
First posted
May 12, 2009
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.