Status:
COMPLETED
A Study to Diagnose Lung Cancer by Sputum Cytology (01-312)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Lung Cancer
Phase:
PHASE3
Brief Summary
The primary objective of this study is to determine if more diagnoses of lung cancer are obtained from the cytological evaluation of sputum expectorated following a single inhaled dose of UTP compared...
Eligibility Criteria
Inclusion
- be suspected of having primary lung cancer based upon chest radiograph(s), CT scan(s), or PET scan(s) and with symptom, risk profile, or history suggestive of malignancy
- have FEV1 greater than or equal to 40% predicted normal for age and height
Exclusion
- have obtained a confirmed diagnosis for the current suspicious lung tumor
- have been treated for the current, suspicious tumor except in cases in which the current lesion is the recurrence of the same tumor (same location) for which treatment was administered no less than 180 days prior to screening
- have undergone a bronchoscopic examination or pulmonary fine needle aspiration biopsy within 4 days prior to dosing, or have undergone sputum induction within 3 days prior to dosing
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2003
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00210080
Start Date
April 1 2001
End Date
December 1 2003
Last Update
September 4 2015
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