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

NCT00625690 | Completed DMC

• 2 other identifiers: 0064-05-FBP30CA036727
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

lung cancer

Outcome Measures

Primary Outcomes (8)

• Feasibility of establishing a lung cancer screening program at the University of Nebraska Medical Center

  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.

  Upon the approximately 5-year establishment of normative parameters in regard to screening efficiency.

• Feasibility of screening 100 high-risk individuals with high-resolution CT scanning for the presence of suspicious pulmonary nodules

  Enrollment of 100 subjects; Baseline and yearly CT evaluations for 4 more years.

  Upon the approximately 5-year establishment of normative parameters in regard to screening efficiency.

• Comparison of work-up on all study participants with abnormal results within a defined time period from initial screening

  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.

  Upon the approximately 5-year establishment of normative parameters in regard to screening efficiency.

• Frequency of suspicious nodules at baseline

  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.

  Upon the approximately 5-year establishment of normative parameters.

• Frequency of invasive procedures for diagnosis

  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.

  Upon the approximately 5-year establishment of normative parameters.

• Frequency of surgical evaluation

  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.

  Upon the approximately 5-year establishment of normative parameters

• Complication rates with diagnostic work-up

  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.

  Upon the approximately 5-year establishment of normative parameters.

• Surgical management

  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.

  Upon the approximately 5-year establishment of normative parameters.

Interventions

questionnaire administration OTHER

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.

computed tomography PROCEDURE

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.

evaluation of cancer risk factors PROCEDURE

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.

study of high risk factors PROCEDURE

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.

Eligibility Criteria

• Age: 19 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Eppley Cancer Center, University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

Location

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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Apar K Ganti, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: February 28, 2008
• Study Start: May 19, 2005
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

US (1)