CT Scans in Screening for Lung Cancer in Current and Former Smokers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Nebraska.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00625690
First received: February 27, 2008
Last updated: February 3, 2011
Last verified: February 2011

February 27, 2008
February 3, 2011
May 2005
December 2011   (final data collection date for primary outcome measure)
  • 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.
  • Feasibility of establishing a lung cancer screening program at the University of Nebraska Medical Center [ Designated as safety issue: No ]
  • Feasibility of screening 100 high-risk individuals with high-resolution CT scanning for the presence of suspicious pulmonary nodules [ Designated as safety issue: No ]
  • Frequency of suspicious nodules at baseline [ Designated as safety issue: No ]
  • Complication rates with diagnostic work-up [ Designated as safety issue: No ]
  • Comparison of work-up on all study participants with abnormal results within a defined time period from initial screening [ Designated as safety issue: No ]
  • Establishment of normative parameters for screening efficiency [ Designated as safety issue: No ]
  • Frequency of invasive procedures for diagnosis [ Designated as safety issue: No ]
  • Frequency of surgical evaluation [ Designated as safety issue: No ]
  • Surgical management [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00625690 on ClinicalTrials.gov Archive Site
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CT Scans in Screening for Lung Cancer in Current and Former Smokers
Development of a Lung Cancer-Screening Program at the University of Nebraska Medical Center: A Feasibility Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.

Non-Probability Sample

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

Lung Cancer
  • Other: questionnaire administration
    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.
  • Procedure: computed tomography
    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.
  • Procedure: evaluation of cancer risk factors
    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.
  • Procedure: study of high risk factors
    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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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
Not Provided
December 2011   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00625690
064-05, P30CA036727, UNMC-06405
Yes
Apar Ganti, M.D., UNMC Eppley Cancer Center at the University of Nebraska Medical Center
University of Nebraska
National Cancer Institute (NCI)
Principal Investigator: Apar K. Ganti, MD University of Nebraska
University of Nebraska
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP