Summary
The Johns Hopkins Lung Project was a two-arm randomly assigned study designed to determine whether the addition of cytologic screening to the radiographic screening of at-risk volunteers (Male smokers 45 or older) could enhance the early detection of asymptomatic lung cancer and whether early therapeutic intervention in detected cases could significantly reduce the mortality from this disease.
Study Years: 1974-1984
Randomized trial with two arms:
- Arm I: Control: X-ray Only (Only annual PA and lateral chest roentgenograms)
- Arm II: Screening: Dual-screen (Similar roentgenographic examinations as well as sputum cytology examinations every 4 months)
Study Eligibility:
- Ages Eligible for Study: 45 or older
- Sexes Eligible for Study: Male
- Smoked at least 1 pack of cigarettes per day (or who had smoked this much within one year of enrollment)
- No prior history of respiratory tract cancer
- From the Baltimore metropolitan area
Enrollment
Enrollment: 10,828
- 5,421 in Control Arm (5,226 eligible)
- 5,407 in Screening Arm (5,160 eligible)
Total Study Population Demographics (10,386 Randomized and Eligible People):
Study Population Age Demographics
| Age |
Control |
Screening |
| # |
% |
# |
% |
| 45-49 |
1599 |
31 |
1649 |
31.6 |
| 50-54 |
1412 |
27.4 |
1410 |
27 |
| 55-59 |
1046 |
20.3 |
1020 |
19.5 |
| 60-64 |
657 |
12.7 |
653 |
12.5 |
| 65-69 |
325 |
6.3 |
358 |
6.9 |
| 70+ |
121 |
2.3 |
136 |
2.6 |
Study Population Race Demographics
| Race |
Control |
Screening |
| # |
% |
# |
% |
| White |
4404 |
85.3 |
4557 |
87.2 |
| Black |
701 |
13.6 |
621 |
11.9 |
| Other |
55 |
1.1 |
48 |
0.9 |
Schema
The Schema is a timeline of the study. It indicates start/end points, visits expected, major testing to be done, and any other information that is crucial to understanding how the study was completed.
Schema Description
The study enrolled 10,828 at-risk males. At study entry, all subjects completed a questionnaire that elicited information regarding demographics, smoking history, and exposure to other lung cancer risk factors. Eligible participants were randomized by computer to either a dual-screen or x-ray only group. Each group completed an annual questionnaire and exam during which posterior-anterior and lateral chest x-rays were obtained. In the dual-screen group, sputum was collected at the annual exam after saline aerosol induction. Immediately following each annual exam and at four and again eight months later, dual-screen participants were instructed to collect at home their first sputum upon rising for three consecutive morning. Screening continued for 5-7 years. For all deaths identified during follow-up, death certificates were requested, as were relevant clinical records pertaining to cause of death.
-
At-risk male volunteers
-
Initial Questionnaire
-
Randomization
-
Dual-screen Arm
(Screening)
-
Year 1: Cytology and X-ray
-
4 Months: Cytology
-
8 Months: Cytology
-
Year 2: Cytology, X-ray, and Follow-up Questionnaire
-
4 Months: Cytology
-
8 Months: Cytology
-
Year 3: Cytology, X-ray, and Follow-up Questionnaire
X-ray Only Arm
(Control)
-
-
Study End
