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

• ClinicalTrials.gov Identifier: NCT00210080
• Recruitment Status: Completed
• First Posted: September 21, 2005
• Last Update Posted: September 4, 2015
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

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.

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

Study Design

• 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

Arms and Interventions

Outcome Measures

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

• 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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme Corp.

More Information

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00210080
• Other Study ID Numbers: 01-312
• First Posted: September 21, 2005
• Last Update Posted: September 4, 2015
• Last Verified: September 2015

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases