NCT00033527

Brief 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.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2002

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

October 22, 2003

Completed
Last Updated

November 6, 2013

Status Verified

September 1, 2002

First QC Date

April 9, 2002

Last Update Submit

November 5, 2013

Conditions

Lung Cancer

Keywords

non-small cell lung cancersmall cell lung cancer

Interventions

INS316DRUG
sputum cytologyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Jenny T. Mao, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2002

First Posted

October 22, 2003

Last Updated

November 6, 2013

Record last verified: 2002-09