Biomarkers in Tissue and Blood Samples From Patients With Early-Stage Non-Small Cell Lung Cancer
NCT ID: NCT01139944
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
99 participants
OBSERVATIONAL
2010-07-31
2014-01-31
Brief Summary
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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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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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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.
DNA methylation analysis
polymerase chain reaction
laboratory biomarker analysis
Interventions
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DNA methylation analysis
polymerase chain reaction
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Malcolm V. Brock, MD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other Identifiers
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ACOSOG-Z4102
Identifier Type: -
Identifier Source: secondary_id
CDR0000671680
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z4102
Identifier Type: -
Identifier Source: org_study_id
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