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

NCT ID: NCT00899535

Last Updated: 2016-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

DNA analysis

Intervention Type GENETIC

RNA analysis

Intervention Type GENETIC

microarray analysis

Intervention Type GENETIC

mutation analysis

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

Interventions

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DNA analysis

Intervention Type GENETIC

RNA analysis

Intervention Type GENETIC

microarray analysis

Intervention Type GENETIC

mutation analysis

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Allen, MD

Role: STUDY_CHAIR

Mayo Clinic

Other Identifiers

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ACOSOG-Z4082

Identifier Type: -

Identifier Source: secondary_id

CDR0000617514

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACOSOG-Z4082

Identifier Type: -

Identifier Source: org_study_id

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