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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Lung Cancer

Treatments: Genetic: polymerase chain reaction; Genetic: DNA methylation analysis; Other: laboratory biomarker analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01139944

ACOSOG-Z4102

CDR0000671680 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

99 participants in 1 patient group

Group 1

Description:

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.

Treatment:

Other: laboratory biomarker analysis

Genetic: polymerase chain reaction

Genetic: DNA methylation analysis