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Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

RATIONALE: Studying samples of blood and tissue from smokers (closed to entry as of 7/15/07) and non-smokers with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about risk factors for lung cancer and may help the study of cancer in the future. PURPOSE: This clinical trial is studying carcinogens in lung tissue from smokers (closed to entry as of 7/15/07) and non-smokers with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically confirmed non-small cell lung cancer

- Stage I, II, IIIA, or IIIB (T4 or N3) disease

- No malignant pleural effusion; if pleural fluid is present, 1 of the following
criteria must be met:

- Benign pleural fluid

- Pleural fluid is due to prior thoracotomy

- Pleural fluid is deemed too small to safely tap

- No diagnosis by cytology alone

- Newly diagnosed disease

- Must have tumor blocks/slides available and must be willing to provide tissue samples

- Prior smoking history meeting 1 of the following criteria:

- Never smoker, defined as < 100 cigarettes in lifetime

- Former smoker, defined as no smoking for ≥ 1 year

- Current smoker, defined as all others (closed to accrual as of 7/15/07)

- No pericardial effusions

PATIENT CHARACTERISTICS:

- No other prior malignancy except for 1 of the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Other cancer for which the patient has been disease free for five years

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiotherapy

- Concurrent participation in therapeutic trials allowed

Gender: Both
Steward Physician(s)
  • Christine B. Ambrosone, PhD
  • Regina M. Santella, PhD
  • Kathy S. Albain, MD
  • Paul H. Gumerlock, PhD
Facilities
  • Holy Family Hospital - Completed
  • Norwood Hospital - Completed
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Genetic
  • chromogenic in situ hybridization
  • gene expression analysis
  • mutation analysis
  • polymerase chain reaction
  • polymorphism analysis
Other
  • fluorescent antibody technique
  • immunohistochemistry staining method
  • laboratory biomarker analysis
  • matrix-assisted laser desorption/ionization time of flight mass spectrometry
  • study of socioeconomic and demographic variables
Procedure
  • study of high risk factors
Physician Researcher

Investigator Name:

  • Christine B. Ambrosone, PhD
  • Regina M. Santella, PhD
  • Kathy S. Albain, MD
  • Paul H. Gumerlock, PhD

Other Information

Sponsor: Southwest Oncology Group
Phase: N/A
Trial ID: NCT00450281
Volunteers:  Not Accepting Healthy Volunteers

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