Back to resultsA Study to Diagnose Lung Cancer by Sputum Cytology (01-312)
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Uridine 5'-Triphosphate (UTP) Solution for Inhalation
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
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
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00210080
First Posted
September 13, 2005
Last Updated
September 3, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00210080
Brief Title
A Study to Diagnose Lung Cancer by Sputum Cytology (01-312)
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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 to sputum expectorated following a single inhaled dose of placebo in patients suspected of having lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
700 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Uridine 5'-Triphosphate (UTP) Solution for Inhalation
Primary Outcome Measure Information:
Title
Proportion of lung cancers (malignancies) diagnosed by sputum cytology
Secondary Outcome Measure Information:
Title
Proportion of centrally and peripherally located lung cancers diagnosed by sputum cytology;
Title
Proportion of small and large lung cancers diagnosed by sputum cytology;
Title
Proportion of lung cancers of various cell types, stages and resectability diagnosed by sputum cytology;
Title
Wet weight of sputum expectorated;
Title
Macrophage content of sputum
10. Eligibility
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Diagnose Lung Cancer by Sputum Cytology (01-312)
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