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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2009 by National Cancer Institute (NCI).
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00899535

First received: May 9, 2009

Last updated: NA

Last verified: April 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

May 9, 2009

Start Date ^ICMJE

October 2008

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Genetic: DNA analysis
Genetic: RNA analysis
Genetic: microarray analysis
Genetic: mutation analysis
Genetic: polymorphism analysis

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1000

Completion Date

Not Provided

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00899535

Other Study ID Numbers ^ICMJE

CDR0000617514, ACOSOG-Z4082

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

American College of Surgeons

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Mark S. Allen, MD

Mayo Clinic

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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