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A Study to Diagnose Lung Cancer by Sputum Cytology (01-312)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00210080
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Uridine 5'-Triphosphate (UTP) Solution for Inhalation Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Proportion of lung cancers (malignancies) diagnosed by sputum cytology

Secondary Outcome Measures :
  1. Proportion of centrally and peripherally located lung cancers diagnosed by sputum cytology;
  2. Proportion of small and large lung cancers diagnosed by sputum cytology;
  3. Proportion of lung cancers of various cell types, stages and resectability diagnosed by sputum cytology;
  4. Wet weight of sputum expectorated;
  5. Macrophage content of sputum

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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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
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases