NCT00103363

Brief Summary

RATIONALE: Screening tests, such as sputum cytology, may help doctors find tumor cells early and plan better treatment for lung cancer. PURPOSE: This phase II trial is studying how well sputum cytology works in screening heavy smokers for lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,270

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Feb 1993

Shorter than P25 for phase_2 lung-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1993

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 1994

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 1994

Completed
11 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2005

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

February 7, 2005

Last Update Submit

May 5, 2014

Conditions

Lung Cancer

Keywords

non-small cell lung cancersmall cell lung cancer

Outcome Measures

Primary Outcomes (3)

  • Classification of annual sputum samples cytologically

  • Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence

  • Correlation of changes in sputum cytology with lung cancer incidence

Secondary Outcomes (1)

  • Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk

Interventions

cytology specimen collection procedureOTHER
physiologic testingOTHER
annual screeningPROCEDURE
study of high risk factorsPROCEDURE

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Current or ex-smoker with a lifetime history of cigarette smoking of ≥ 20 pack years, meeting 1 of the following criteria: * Airflow obstruction * FEV\_1 \< 75% predicted for age by spirometry * FEV\_1/FVC ≤ 75% by spirometry * No airflow obstruction * No history of lung cancer PATIENT CHARACTERISTICS: Age * 25 and over Performance status * Not specified Life expectancy * More than 5 years Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No cancer within the past 5 years except nonmelanoma skin cancer 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)

University of Colorado Health Sciences Center - Denver

Denver, Colorado, 80262, United States

Location

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

  • Timothy Kennedy

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
SCREENING
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2005

First Posted

February 8, 2005

Study Start

February 1, 1993

Primary Completion

February 1, 1994

Study Completion

February 1, 1994

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations

US(1)