CT Scans in Screening for Lung Cancer in Current and Former Smokers
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| ClinicalTrials.gov Identifier: NCT00625690 |
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Recruitment Status :
Active, not recruiting
First Posted : February 28, 2008
Last Update Posted : September 14, 2018
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Sponsor:
University of Nebraska
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Apar Kishor Ganti, MD, University of Nebraska
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Brief Summary:
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 or disease | Intervention/treatment |
|---|---|
| Lung Cancer | Other: questionnaire administration Procedure: computed tomography Procedure: evaluation of cancer risk factors Procedure: study of high risk factors |
Show Detailed Description
| Study Type : | Observational |
| Actual Enrollment : | 100 participants |
| 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 |
| Study Start Date : | May 2005 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | December 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
Intervention Details:
- 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.
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. ]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. ]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. ]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. ]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. ]
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 ]
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. ]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. ]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.
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| Ages Eligible for Study: | 19 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Apar Kishor Ganti, MD, Principal Investigator, University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT00625690 History of Changes |
| Other Study ID Numbers: |
064-05 P30CA036727 ( U.S. NIH Grant/Contract ) UNMC-06405 |
| First Posted: | February 28, 2008 Key Record Dates |
| Last Update Posted: | September 14, 2018 |
| Last Verified: | September 2018 |
Keywords provided by Apar Kishor Ganti, MD, University of Nebraska:
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lung cancer |
Additional relevant MeSH terms:
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Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |