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Epigenetic Changes as Prognostic Markers in Patients With Early Stage Non-Small Cell Lung Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Epigenetic Changes as Prognostic Markers in Patients With Early Stage Non-Small Cell Lung Cancer


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Aberrant DNA methylation patterns

Safety Issue:

No

Principal Investigator

Malcolm V. Brock, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

Unspecified

Study ID:

CDR0000671680

NCT ID:

NCT01139944

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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