Screening for Lung Cancer in Older Patients (PLCO Screening Trial)
This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for lung cancer
Other: screening questionnaire administration
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
|Official Title:||Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial|
- Lung cancer-specific mortality rate [ Time Frame: Up to 13 years ] [ Designated as safety issue: Yes ]Event rates defined as the ratio of the number of events (deaths) to the person-years at the risk for the event.
- Lung cancer-specific incidence rate [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]Event rates defined as the ratio of the number of events (diagnosis) to the person-years at the risk for the event.
|Study Start Date:||November 1993|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
No Intervention: Control
Participants receive standard medical care. Participants complete a DHQ at baseline.
Active Comparator: 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. Participants complete a BQF/M at baseline. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the 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.
Undergo a chest x-ray
Other Names:Other: screening questionnaire administration
Undergo questionnaire assessments
I. To determine whether screening with chest x-ray can reduce mortality from lung cancer in women and men aged 55-74 at entry.
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.
|United States, Maryland|
|Mark O Hatfield-Warren Grant Magnuson Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Christine Berg||Mark O Hatfield-Warren Grant Magnuson Clinical Center|