A Study to Diagnose Lung Cancer by Sputum Cytology (01-312)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: September 13, 2005
Last updated: September 18, 2013
Last verified: September 2013
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 to sputum expectorated following a single inhaled dose of placebo in patients suspected of having lung cancer.
Drug: Uridine 5'-Triphosphate (UTP) Solution for Inhalation
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A Double-Blind, Placebo-Controlled, Parallel Group Study of Uridine 5'-Triphosphate (UTP) Solution for Inhalation as an Adjunct in the Diagnosis of Lung Cancer by Sputum Cytology
Primary Outcome Measures:
- Proportion of lung cancers (malignancies) diagnosed by sputum cytology
Secondary Outcome Measures:
- Proportion of centrally and peripherally located lung cancers diagnosed by sputum cytology;
- Proportion of small and large lung cancers diagnosed by sputum cytology;
- Proportion of lung cancers of various cell types, stages and resectability diagnosed by sputum cytology;
- Wet weight of sputum expectorated;
- Macrophage content of sputum
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2003 (Final data collection date for primary outcome measure)
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00210080
Merck Sharp & Dohme Corp.
||Amy Schaberg, BSN
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 13, 2005
||September 18, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 20, 2014
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases