Sputum Cytology in Screening Heavy Smokers For Lung Cancer | NCT00103363

Studies
Sputum Cytology in Screening Heavy Smokers For Lung Cancer

NCT00103363

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

May 7, 2014Estimated

Enrollment

3,270Actual

Phase

Phase 2

Conditions

Lung Cancer

Interventions

cytology specimen collection procedure
physiologic testing
annual screening
study of high risk factors

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UCHSC-92-392	Other Identifier	University of Colorado Multiple Institutional Review Board

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1993

Primary Completion Date

Feb 1994Actual

Completion Date

Feb 1994Actual

First Submitted Date

Feb 7, 2005

First Submission Date that Met QC Criteria

Feb 7, 2005

First Posted Date

Feb 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2014

Last Update Posted Date

May 7, 2014Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

OBJECTIVES:

Primary

Classify annual sputum samples cytologically in participants with or without airflow obstruction and a heavy smoking history.
Correlate sputum cytological atypia (moderate atypia or worse) with lung cancer incidence in these participants.
Correlate changes in sputum cytology (i.e., changes toward higher grades of atypia) with lung cancer incidence in these participants.

Secondary

Determine other risk factors for lung cancer (e.g., diet, family history, smoking history, and medications) that may either confound or modify the association between sputum cytology and lung cancer risk in these participants.

OUTLINE: Two 3-day pooled sputum samples are collected for 6 consecutive days from participants by the spontaneous cough technique for cytopathological evaluation. Participants also complete a risk factor questionnaire and undergo a pulmonary function test by spirometry and a blood draw.

Participants complete a questionnaire updating smoking, vital, and lung cancer status and undergo sputum sample collection annually.

Participants are informed of sputum cytology results.

PROJECTED ACCRUAL: A total of 3,400 participants (2,900 with airflow obstruction and 500 without airflow obstruction) will be accrued for this study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,270Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008175	Lung Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung
D055752	Small Cell Lung Carcinoma

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Name	Type	Description	Arm Group Labels	Other Names
cytology specimen collection procedure	Other
physiologic testing	Other
annual screening	Procedure
study of high risk factors	Procedure