| Protocol Number: |
S0424 |
| Trial Phase: |
Specimen/Tissue |
| Maximum # of Subjects: |
720 |
| IRB Number: |
WIRB# 1078335 |
| Study Status: |
Active |
| Enrollment Status: |
Open |
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| The purpose of this study is to determine why women are more likely to be diagnosed with certain types of lung cancer than men are, and to see if factors other than smoking may put women at higher risk of lung cancer than men. |
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Eligibility |
Inclusion Criteria:
1. Patients must have newly diagnosed, primary, histologically confirmed Stage I, II, IIIA or IIIB (T4 or N3, excluding patients with malignant pleural effusion) NSCLC.
2. Patients with effusion eligible if:
- Fluid tapped is benign cytology and all physicans concure that it is from a benign etiology.
- Fluid present after mediastinoscopy or thoracotomy, but not before.
- Fluid deemed too small to tap under CT or U/S guidance.
3. May be registered concurrently to a therapeutic study, but not required to be on a therapeutic study.
4. Must have tumor block/slides available and willing to provide tissue and a blood sample for testing.
5. Able and willing to complete Lung Cancer Epidemiology Questionnaire . Must be able to read and understand English.
6. Must be identified and registered within 120 days of diagnosis. Final staging must be determined within 42 days prior to registration.
7. Must be willing to provide prior smoking history. |
Exclusion Criteria:
1. Diagnosis by cytology alone.
2. Malignant pleural effusion.
3. No other prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer or in situ cervical cancer.
4. Prior systemic chemotherapy or radiation therapy for cancer.
5. Pericardial effusions. |
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