Development of a Lung Cancer-Screening Program at the University of Nebraska Medical Center: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Feasibility of establishing a lung cancer screening program at the University of Nebraska Medical Center
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current and former smokers with at least a 30 pack-year history of smoking
- •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
- •Able to come to clinic for screening
排除标准
- •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
- •No condition that would preclude screening, diagnosis, or surgical treatment
- •Not pregnant/negative pregnancy test
结局指标
主要结局
Feasibility of establishing a lung cancer screening program at the University of Nebraska Medical Center
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点