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OpenTrials
Completed

NCT Number: NCT01139944

Biomarkers in Tissue and Blood Samples From Patients With Early-Stage Non-Small Cell Lung Cancer

RATIONALE: Studying samples of blood and 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 studying biomarkers in tissue and blood samples from patients with early-stage non-small cell lung cancer.

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Key information

About this study

OBJECTIVES:

  • Evaluate aberrant methylation patterns in tissue and serum samples from patients with early-stage non-small cell lung cancer (NSCLC) to validate the Johns Hopkins single institutional study.
  • Attempt to define subgroups of patients at greater risk for recurrent or metastatic disease who may benefit from more aggressive adjuvant therapeutic regimens.
  • Develop prognostic indicators for disease-specific and overall survival.
  • Define new potential molecular targets for therapy.

OUTLINE: Archived tumor and intrathoracic lymph node tissue samples are analyzed for aberrant DNA methylation (p16/CDKN2A, DAP kinase, H-cadherin, APC, and RASSF1A) by methylation-specific PCR. Analyses are then compared with the preliminary data from the Johns Hopkins institutional study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of early-stage non-small cell lung cancer
  • T1 or T2, N0 disease
  • Had a lobectomy or greater resection with negative surgical margins (R0 resection)
  • Available tumor and lymph node specimens from patients enrolled on ACOSOG-Z0040 and ACOSOG-Z0030 trials
  • Node-negative with recurrent disease within 3 years (cases)
  • Node-negative patients without recurrent disease (controls)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

DNA methylation analysis

Genetic

polymerase chain reaction

Genetic

laboratory biomarker analysis

Other

Primary outcomes

  1. disease specific survival

    Time frame: Up to 10 years

  2. overall survival

    Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Epigenetic Changes as Prognostic Markers in Patients With Early Stage Non-Small Cell Lung Cancer

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 9, 2010
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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