Clinical trial · Interventional
A Study to Diagnose Lung Cancer by Sputum Cytology (01-312)
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
NCT00210080CI-TRIAL-00019042completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Uridine 5'-Triphosphate (UTP) Solution for Inhalation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of lung cancers (malignancies) diagnosed by sputum cytology
Secondary outcomes (5)
- measure
- Proportion of centrally and peripherally located lung cancers diagnosed by sputum cytology;
- measure
- Proportion of small and large lung cancers diagnosed by sputum cytology;
- measure
- Proportion of lung cancers of various cell types, stages and resectability diagnosed by sputum cytology;
- measure
- Wet weight of sputum expectorated;
- measure
- Macrophage content of sputum
Eligibility
Eligibility (as posted)
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.