Clinical trial 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
Official title: The Cancer Genome Atlas (TCGA) Utilizing Z0030 NSCLC Patient Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: 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
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with non-small cell carcinoma previously registered on ACOSOG-Z0030.

Brief summary: 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.

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 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

Primary outcomes:
measure: Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Mark Allen, MD
role: STUDY_CHAIR
References: