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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00210080

First received: September 13, 2005

Last updated: September 3, 2015

Last verified: September 2015

History of Changes

Purpose

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	Intervention	Phase
Lung Cancer	Drug: Uridine 5'-Triphosphate (UTP) Solution for Inhalation	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

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:	700
Study Start Date:	April 2001
Study Completion Date:	December 2003
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	Child, Adult, Senior

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210080

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 History of Changes
Other Study ID Numbers:	01-312
Study First Received:	September 13, 2005
Last Updated:	September 3, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site	Neoplasms Lung Diseases Respiratory Tract Diseases Pharmaceutical Solutions

ClinicalTrials.gov processed this record on September 23, 2016

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