Biomarkers in Tissue and Blood Samples From Patients With Early-Stage Non-Small Cell Lung Cancer
Recruitment status was Not yet recruiting
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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 |
- 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) |
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 |
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 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 Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013