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OpenTrials
Completed

NCT Number: NCT00210080

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

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.

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Key information

Conditions

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

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uridine 5'-Triphosphate (UTP) Solution for Inhalation

Drug

Primary outcomes

  1. Proportion of lung cancers (malignancies) diagnosed by sputum cytology

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Sep 21, 2005
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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