Clinical trial · Interventional
INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer
A Double-Blinded, 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
NCT00033527CI-TRIAL-00012572unknownN/AClinicalTrials.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)
RATIONALE: INS316 may produce a better sputum sample for laboratory analysis and may provide a less invasive method of diagnosing lung cancer. PURPOSE: Randomized diagnostic trial to compare the effectiveness of INS316 with that of saline for sputum collection in diagnosing lung cancer 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INS316 | Drug | — | UNRESOLVED |
| sputum cytology | Other | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Suspected of having primary lung cancer by chest radiography, CT scan, or positron-emission tomography scan with symptoms, risk profile, or history suggestive of malignancy * No prior confirmed diagnosis for current suspicious lung tumor * Expected to have a histological or cytological confirmation within 8 weeks after study completion * No prior treatment for current suspicious tumor unless current lesion is recurrence of same tumor (in same location) for which prior treatment was received at least 180 days prior to study * FEV\_1 at least 40% predicted PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent comorbid condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * See Disease Characteristics Radiotherapy: * See Disease Characteristics Surgery: * At least 4 days since prior pulmonary fine needle aspiration biopsy * No concurrent mediastinoscopy or thoracotomy Other: * At least 4 days since prior bronchoscopic examination * At least 3 days since prior sputum induction * At least 30 days since prior investigational drugs (including INS316) or experimental therapy * No concurrent medication that would preclude study participation
References
Publications (0)
Data not yet available
No reference posted for this study.