INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

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