Clinical trial NCT00103363: Sputum Cytology in Screening Heavy Smokers For Lung Cancer
Official title: Lung Cancer Screening and Tissue Procurement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: non-small cell lung cancer
small cell lung cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-02-08
Enrollment: 3270
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Classification of annual sputum samples cytologically
measure: Correlation of sputum cytological atypia (moderate atypia or worse) with lung cancer incidence
measure: Correlation of changes in sputum cytology with lung cancer incidence
Secondary outcomes:
measure: Risk factors for lung cancer that may effect the association between sputum cytology and lung cancer risk
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center - Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Timothy Kennedy
role: PRINCIPAL_INVESTIGATOR
References: