Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103363
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2005-02-07
Brief Title:
Sputum Cytology in Screening Heavy Smokers For Lung Cancer
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Lung Cancer Screening and Tissue Procurement
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie changes toward higher grades of atypia with lung cancer incidence in these participants
Secondary
Determine other risk factors for lung cancer eg 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 3400 participants 2900 with airflow obstruction and 500 without airflow obstruction will be accrued for this study
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 ie changes toward higher grades of atypia with lung cancer incidence in these participants
Secondary
Determine other risk factors for lung cancer eg 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 3400 participants 2900 with airflow obstruction and 500 without airflow obstruction will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCHSC-92-392 | OTHER | University of Colorado Multiple Institutional Review Board | None |