CT Scans in Screening for Lung Cancer in Current and Former Smokers - Full Text View

Purpose

RATIONALE: Screening tests, such as CT scanning, may help doctors find cancer cells early and plan better treatment for lung cancer.

PURPOSE: This clinical trial is studying how well a lung cancer screening program using CT scanning works in current and former smokers.

Condition	Intervention
Lung Cancer	Other: questionnaire administration Procedure: computed tomography Procedure: evaluation of cancer risk factors Procedure: study of high risk factors

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Development of a Lung Cancer-Screening Program at the University of Nebraska Medical Center: A Feasibility Study

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Lung Cancer Nuclear Scans

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:

Feasibility of establishing a lung cancer screening program at the University of Nebraska Medical Center [ Time Frame: Upon the approximately 5-year establishment of normative parameters in regard to screening efficiency. ] [ Designated as safety issue: No ]
Frequency of suspicious nodules on baseline CT; Frequency of invasive procedures for diagnosis; Frequency of surgical evaluation; Complication rates with diagnostic work up as well as surgical management.
Feasibility of screening 100 high-risk individuals with high-resolution CT scanning for the presence of suspicious pulmonary nodules [ Time Frame: Upon the approximately 5-year establishment of normative parameters in regard to screening efficiency. ] [ Designated as safety issue: No ]
Enrollment of 100 subjects; Baseline and yearly CT evaluations for 4 more years.
Comparison of work-up on all study participants with abnormal results within a defined time period from initial screening [ Time Frame: Upon the approximately 5-year establishment of normative parameters in regard to screening efficiency. ] [ Designated as safety issue: No ]
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. 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.
Frequency of suspicious nodules at baseline [ Time Frame: Upon the approximately 5-year establishment of normative parameters. ] [ Designated as safety issue: No ]
Study participants undergo a low-dose spiral CT scan at baseline. 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.
Frequency of invasive procedures for diagnosis [ Time Frame: Upon the approximately 5-year establishment of normative parameters. ] [ Designated as safety issue: No ]
Non-calcified solid nodules ≥ 5 and ≤ 15 mm: 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: Additional diagnostic work-up, if appropriate, as described previously.

Non-calcified solid nodules > 15 mm: Work-up for a positive nodule, as above.
Frequency of surgical evaluation [ Time Frame: Upon the approximately 5-year establishment of normative parameters ] [ Designated as safety issue: No ]
Non-calcified solid nodules ≥ 5 and ≤ 15 mm: 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: Additional diagnostic work-up, if appropriate, as described previously.

Non-calcified solid nodules > 15 mm: Work-up for a positive nodule, as above.
Complication rates with diagnostic work-up [ Time Frame: Upon the approximately 5-year establishment of normative parameters. ] [ Designated as safety issue: No ]
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.
Surgical management [ Time Frame: Upon the approximately 5-year establishment of normative parameters. ] [ Designated as safety issue: No ]
If malignancy is diagnosed, that patient after definitive intervention will be followed for progression-free survival and cancer-related mortality. In case the subject develops any malignancy, the subject will be taken off study but the course of the malignancy, including survival will be monitored.

Biospecimen Retention: Samples Without DNA

Collection of blood sample: At the time of the initial CT scan, every subject will be asked to donate a small blood sample, approximately 10 ml in a yellow EDTA tube (less than 1 tablespoon) from their arm by standard blood drawing techniques, for storage for use in future studies. The blood sample will be number coded, and serum from the blood sample will be stored frozen and held at UNMC for future studies. All studies will be proposed in future IRB submissions.

Enrollment:	100
Study Start Date:	May 2005
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Subjects will be asked to complete an additional detailed questionnaire regarding personal information about themselves, their medical history, their diet and lifestyle habits, any past or current environmental exposures and to re-create their family tree for any cancers that have occurred in any of their family members.

The baseline and repeat screening CT scans will be performed with a multi-slice helical CT scanner (8 or more rows), at a low-dose setting (120kVp, 40-80mA, slice thickness of 1.25 mm or less). In a single breath-hold, contiguous slices from the thoracic inlet to the adrenal glands will be obtained. Contrast material will not be used. Multi-slice scanners will be used because they provide higher-resolution images. Diagnostic studies, including HRCT will be performed with a multi-slice helical CT at diagnostic settings (120kVp, 140-300mA, slice thickness of 1.25 or less) with the nodule retrospectively reconstructed at a 15cm field of view.

When the CT scan at baseline does not lead to the diagnosis of malignancy, repeat screening will be scheduled 12 months later. If the initial scan led to further evaluation, the repeat scan will be performed 12 months after the most recent scan. The subjects will be allowed to add relevant health information to their record in the web-based database as it develops. Similarly, when in the first repeat screening malignancy is not diagnosed; the second repeat screening will be scheduled 12 months later for a total period of 5 years.

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Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Normal subjects with at least a 30 pack-year history of cigarette smoking.

Criteria

DISEASE CHARACTERISTICS:

Current and former smokers with at least a 30 pack-year history of smoking

PATIENT CHARACTERISTICS:

Body weight less than 140 kg (308 pounds)
Able to lie flat
Able to comply with long-term follow-up
Functional capacity and willingness to undergo diagnostic work-up of suspicious nodules and curative therapy if lung cancer is detected
Nursing mothers allowed
No cognitive impairment that would preclude providing informed consent
No other concurrent or prior malignancy within the past five years except superficial basal cell carcinoma or nonmelanoma skin cancer
Able to come to clinic for screening
No condition that would preclude screening, diagnosis, or surgical treatment
Not pregnant
Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625690

Locations

United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805

Sponsors and Collaborators

University of Nebraska

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Apar K. Ganti, MD

University of Nebraska

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Apar Ganti, M.D., UNMC Eppley Cancer Center at the University of Nebraska Medical Center
ClinicalTrials.gov Identifier:	NCT00625690 History of Changes
Other Study ID Numbers:	064-05, P30CA036727, UNMC-06405
Study First Received:	February 27, 2008
Last Updated:	February 3, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Nebraska:

lung cancer

Additional relevant MeSH terms:

Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013