Trial Information

Development of a Lung Cancer-Screening Program at the University of Nebraska Medical Center: A Feasibility Study

OBJECTIVES:

- To assess the feasibility of establishing a lung cancer screening program at the
University of Nebraska Medical Center using CT scanning in normal study participants
with at least a 30 pack-year history of cigarette smoking.

- To determine if it is possible to screen 100 high-risk individuals with high-resolution
CT scanning for the presence of suspicious pulmonary nodules.

- To compare an effective and definitive work-up on all study participants with abnormal
results within a defined time period from initial screening.

OUTLINE: Study participants complete a detailed questionnaire (paper or electronic version)
at baseline to provide personal and family information for inclusion in the registry
database. Registry data includes information on participants' medical history, diet,
lifestyle habits, and any past or current environmental exposures, as well as family history
of cancer within each participant's extended family tree. An instruction manual on
completing the questionnaires is provided to all study participants. The System Coordinator
of the registry may provide additional information or clarification of the information
provided in the questionnaires via a structured telephone interview. Data on study
participants and their families is entered into the registry database either manually via
the paper-based questionnaires or electronically via interactive Web-based questionnaires
completed by participants through the registry website.

Study participants also undergo a low-dose spiral CT scan at baseline. The resulting images
are stored electronically and linked to the web-based participant registry. A radiologist
then reviews the images, reports on any abnormalities, and renders an interpretation of the
scan as being positive or negative for lung nodules. The radiologist's findings are then
conveyed to the study participant's primary care physician and the following determinations
are made: participants with negative findings (i.e., non-calcified solid nodules < 5 mm or
non-solid nodules < 8 mm) are returned home and scheduled for a repeat CT scan in 1 year;
participants with abnormalities not related to lung cancer are referred to their primary
care physician for further action; and participants with positive findings undergo
additional diagnostic work-up and treatment* as described below.

- Non-calcified solid nodules ≥ 5 and ≤ 15 mm: Study participants undergo a course of
antibiotics followed by a high-resolution CT scan at 3 months. If the CT findings are
stable, then participants return for a repeat CT scan in 1 year. If the nodules are
growing, participants undergo additional diagnostic work-up, which may include biopsy
of the positive nodule by their treating clinician.

- Non-solid nodule ≥ 8 mm: Study participants undergo treatment with an antibiotic, CT
follow-up, and additional diagnostic work-up, if appropriate, as described previously.

- Non-calcified solid nodules > 15 mm: Study participants undergo work-up for a positive
nodule, as above.

NOTE: *Study participants who demonstrate radiographic abnormalities that are suspected to
be of an inflammatory nature are given a 10-day course of a broad spectrum respiratory
antibiotic, preferably a fluoroquinolone, by the participating physician who enrolled that
participant into the study.

Study participants with negative CT findings undergo CT screening once yearly for up to five
years, in the absence of a diagnosed malignancy. Diagnostic work-up for repeat CT scans is
as follows:

- Any new lesion: Study participants undergo a work-up as previously described for
non-calcified solid or non-solid nodules.

- Any non-calcified nodule that was present earlier and grew in size:

- Growth < 3 mm: Study participants undergo a repeat CT scan in 6 months. If there
is further growth, participants are worked-up for a positive nodule, or, if the
scan is stable, participants undergo a repeat scan 1 year after the most recent
scan.

- Growth between 3 mm and 5 mm: Study participants undergo a high-resolution CT scan
in 3 months and further diagnostic work-up for a positive nodule, as described
previously, if there is growth. If there is complete resolution of the nodule,
participants undergo repeat screening CT scan in 1 year after the most recent
scan. If there is partial resolution of the nodule, another high-resolution CT
scan is performed 3 months later. Participants with a stable nodule undergo repeat
screening CT scan 1 year after the most recent scan.

- Growth ≥ 5 mm: Study participants receive a course of an antibiotic and undergo
high-resolution CT scanning after 1 month. The following assessments are also
performed: work-up for a positive nodule, if there is further growth; repeat
screening CT scan in 1 year after the most recent scan, if there is complete
resolution of the nodule; high-resolution CT scan in 3 months, if there is partial
resolution of the nodule; and repeat screening CT scan 1 year after the most
recent scan, if the nodule is stable.

All study participants undergo blood sample collection at baseline for use in future
studies. Additional blood samples are obtained from study participants with positive CT
scans for future research on smoking-related diseases. Tissue samples obtained from
diagnostic biopsy or surgical specimens are also stored for future research.

Once a malignancy is diagnosed and a definitive intervention is performed, study
participants are followed periodically thereafter.