NCT00012103

Brief Summary

RATIONALE: Imaging procedures such as computed tomography may improve the ability to detect lung cancer earlier. PURPOSE: Screening and diagnostic study of computed tomography in women who are at risk for lung cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2001

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2011

Enrollment Period

2.3 years

First QC Date

March 3, 2001

Last Update Submit

March 25, 2011

Conditions

Lung Cancer

Keywords

non-small cell lung cancersmall cell lung cancer

Interventions

bronchoalveolar lavageOTHER
screening questionnaire administrationOTHER
sputum cytologyOTHER
bronchoscopic and lung imaging studiesPROCEDURE
bronchoscopyPROCEDURE
computed tomographyPROCEDURE
study of high risk factorsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Women who currently smoke or have smoking history of at least a 30 pack year * Pack year is defined by the number of pack(s) of cigarettes per day times the number of years of smoking * No history of prior lung cancer PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No prior cancer within the past 5 years except basal cell or superficial skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

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

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

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

Interventions

Bronchoalveolar LavageBronchoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative TechniquesDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Abraham Chachoua, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SCREENING
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2001

First Posted

January 27, 2003

Study Start

September 1, 1999

Primary Completion

December 1, 2001

Last Updated

March 28, 2011

Record last verified: 2011-03

Locations

US(1)