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Lung Cancer Screening and Tissue Procurement


Phase 2
25 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Lung Cancer Screening and Tissue Procurement


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Screening

Outcome Measure:

Classification of annual sputum samples cytologically

Safety Issue:

No

Principal Investigator

Timothy Kennedy

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Federal Government

Study ID:

92-0392

NCT ID:

NCT00103363

Start Date:

February 1993

Completion Date:

February 1994

Related Keywords:

  • Lung Cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • Lung Neoplasms

Name

Location

University of Colorado Health Sciences Center - DenverDenver, Colorado  80262