NCT Number: NCT01139944
Biomarkers in Tissue and Blood Samples From Patients With Early-Stage Non-Small Cell Lung Cancer
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
polymerase chain reaction
Geneticlaboratory biomarker analysis
OtherPrimary outcomes
-
disease specific survival
Time frame: Up to 10 years
-
overall survival
Time frame: Up to 10 years
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Epigenetic Changes as Prognostic Markers in Patients With Early Stage Non-Small Cell Lung Cancer
Important dates
- Study start
- 2010
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jun 9, 2010
- Registry last updated
- Jul 6, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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