A Study to Diagnose Lung Cancer by Sputum Cytology (01-312)
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ClinicalTrials.gov Identifier: NCT00210080 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : September 4, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer | Drug: Uridine 5'-Triphosphate (UTP) Solution for Inhalation | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 700 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | April 2001 |
Actual Primary Completion Date : | December 2003 |
Actual Study Completion Date : | December 2003 |

- Proportion of lung cancers (malignancies) diagnosed by sputum cytology
- 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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210080
Study Director: | Medical Director | Merck Sharp & Dohme LLC |
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT00210080 |
Other Study ID Numbers: |
01-312 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | September 4, 2015 |
Last Verified: | September 2015 |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |