Lung CancerNCT00625690
CT Scans in Screening for Lung Cancer in Current and Former Smokers
An observational study of Lung Cancer, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- questionnaire administration, computed tomography and evaluation of cancer risk factors
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2005to 1 Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Normal subjects with at least a 30 pack-year history of cigarette smoking.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Eppley Cancer Center, University of Nebraska Medical Center
Omaha, Nebraska, 68198-6805
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Lung Cancer
- Being tested
- questionnaire administration, computed tomography, evaluation of cancer risk factors, study of high risk factors
- Keywords
- lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
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 tomographyProcedure or surgery
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 factorsProcedure or surgery
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 factorsProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Upon the approximately 5-year establishment of normative parameters.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study start19 May 2005
- Primary completion1 Dec 2012
- Study completion1 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Apar K Ganti, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625690
- Sponsor's protocol ID
- 0064-05-FB
- Other IDs
- P30CA036727
- Status last verified
- Sep 2023
- First submitted
- 27 Feb 2008
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Lung Cancer-Screening Program at the University of Nebraska Medical Center: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00625690
- Acronym / sponsor ID
- 0064-05-FB
- Conditions
- Lung Cancer
- Keywords
- lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 May 2005 (actual)
- Primary completion
- 1 Dec 2012 (actual)
- Study completion
- 1 Dec 2012 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Normal subjects with at least a 30 pack-year history of cigarette smoking.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administrationSubjects 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. | Other | – |
| computed tomographyThe 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 or surgery | – |
| evaluation of cancer risk factorsWhen 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 or surgery | – |
| study of high risk factorsWhen 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 or surgery | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Apar K Ganti, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.