A Phase 2 interventional study of cytology specimen collection procedure and physiologic testing in Lung Cancer, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2014-05-07.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Screening
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.
OBJECTIVES:
Primary
Secondary
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 3,270 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 316 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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
Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver