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

June 27, 2016 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

70

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with non-small cell carcinoma previously registered on ACOSOG-Z0030.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Genetic: polymorphism analysis
Genetic: mutation analysis
Genetic: DNA analysis
Genetic: RNA analysis
Genetic: microarray analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Mark Allen, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACOSOG-Z4082
  • CDR0000617514 (Registry Identifier: NCI Physician Reference Desk)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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