Screening for Lung Cancer in Older Patients (PLCO Screening Trial)

PRIMARY OBJECTIVES:

I. To determine whether screening with chest x-ray can reduce mortality from lung cancer in
women and men aged 55-74 at entry.

SECONDARY OBJECTIVES:

I. To assess screening variables, other than mortality, for each of the interventions
including sensitivity, specificity, and positive predictive value.

II. To assess the incidence, stage, and survival of cancer cases. III. To investigate the
mortality predictive value of biologic and/or prognostic characterizations of tumor tissue as
intermediate endpoints.

IV. To conduct biomolecular and genetic research into factors associated with cancer
carcinogenesis and promotion, as well as the early detection of these factors.

OUTLINE: Participants in the overall PLCO study are stratified by screening center, gender,
and age (55-59 vs 60-64 vs 65-69 vs 70-74). Participants are randomized to 1 of 2 arms
(control vs screening).

ARM I (Control): Participants receive standard medical care. Participants complete a Diet
History Questionnaire (DHQ) at baseline.

ARM II (Lung Screening): Participants undergo a chest x-ray (one postero-anterior view) at
baseline and annually for 2 years. Participants classified as "smokers" undergo an additional
chest x-ray at year 3. A scheduling and tracking procedure is implemented to ensure regular
attendance at repeat screens for participants screened negative or for those who are
designated suspicious or positive at screening but for whom subsequent diagnostic procedures
do not reveal lung cancer (follow-up diagnostic procedures are through their own medical care
environment). Participants diagnosed with lung cancer via a screening test are referred for
treatment in accordance with current accepted practice for appropriate stage of disease,
patient age, and medical condition; a procedure is provided for contact with qualified
medical personnel to insure appropriate therapy.

Participants complete a Baseline Questionnaire (BQF/M) to assess smoking status. Participants
complete a Dietary Questionnaire (DQX) at baseline and DHQ at year 3. An Annual Study Update
(ADU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed
to each participant annually for 13 years to identify all prevalent and incident lung cancers
as all deaths that occur among both screened and control subjects during the trial.

After completion of screening, participants are followed up for at least 13 years.

Exclusion Criteria:

- Men and women who at the time of randomization are less than 55 or greater than or
equal to 75 years of age

- Individuals undergoing treatment for cancer at this time, excluding basal-cell and
squamous-cell skin cancer

- Individuals with known prior cancer of the colon, rectum, lung, prostate (men only) or
ovary (women only)

- This includes primary or metastatic PLCO cancers

- Individuals with previous surgical removal of the entire colon, one lung, or the
entire prostate (men only)

- Until October 1996, women with previous surgical removal of both ovaries were
excluded from the trial. In order to increase the enrollment of women into the
trial, beginning in October 1996, these women were no longer excluded for this
reason.

- Individuals who are participating in another cancer screening or cancer primary
prevention trial

- Males who have taken Proscar/Propecia/finasteride in the past 6 months

- NOTE: Individuals who are already enrolled in the trial when their physician
prescribes finasteride are not prevented from taking this medication. As a
result, these participants will continue to be screened and followed just as
those participants who are not on finasteride.

- NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO
Screening Trial.

- Prior to April 1, 1999 women were excluded from the trial if they were currently
taking or had taken Tamoxifen or Evista\Raloxifene in the past 6 months. As of
April 1999 based on a decision from the PLCO Ovary Subcommittee, women who have
or are currently taking Tamoxifen or Evista\Raloxifene are not excluded from
participation.

- Individuals who are unwilling or unable to sign the informed consent form

- Males who have had more than one PSA blood test in the past three years

- Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past
three years