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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01139944
First received: June 8, 2010
Last updated: July 14, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention
Lung Cancer
Genetic: DNA methylation analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Epigenetic Changes as Prognostic Markers in Patients With Early Stage Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • disease specific survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

tissue and blood samples


Enrollment: 99
Study Start Date: July 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
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.
Genetic: DNA methylation analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with early stage non-small cell lung cancer and previously enrolled on ACOSOG-Z0040 and Z0030.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139944

Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Principal Investigator: Malcolm V. Brock, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01139944     History of Changes
Other Study ID Numbers: ACOSOG-Z4102, ACOSOG-Z4102, CDR0000671680
Study First Received: June 8, 2010
Last Updated: July 14, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
squamous cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on August 27, 2015