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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01139944
First Posted: June 9, 2010
Last Update Posted: July 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
  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 ]
  • overall survival [ Time Frame: Up to 10 years ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139944


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

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01139944     History of Changes
Other Study ID Numbers: ACOSOG-Z4102
CDR0000671680 ( Registry Identifier: NCI Physician Data Query )
First Submitted: June 8, 2010
First Posted: June 9, 2010
Last Update Posted: July 6, 2016
Last Verified: July 2016

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