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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01139944
First received: June 8, 2010
Last updated: July 28, 2010
Last verified: June 2010
  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
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Aberrant DNA methylation patterns [ Designated as safety issue: No ]
  • Definition of subgroups of patients at greater risk for recurrent or metastatic disease [ Designated as safety issue: No ]
  • Prognostic indicators for disease-specific and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 99
Study Start Date: July 2010
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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
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)

PATIENT CHARACTERISTICS:

  • Not specified

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
American College of Surgeons
Investigators
Principal Investigator: Malcolm V. Brock, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Susan C. Budinger, American College of Surgeons Oncology Group
ClinicalTrials.gov Identifier: NCT01139944     History of Changes
Other Study ID Numbers: CDR0000671680, ACOSOG-Z4102
Study First Received: June 8, 2010
Last Updated: July 28, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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 October 23, 2014