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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899535
• Other study ID #: ACOSOG-Z4082
• Secondary ID: ACOSOG-Z4082CDR0
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: June 27, 2016
• Start date: October 2008
• Est. completion date: February 2013

Study information

• Verified date: June 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2013
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Genetic:
• DNA analysis

• RNA analysis

• microarray analysis

• mutation analysis

• polymorphism analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens		Up to 3 years	No