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Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Screening |
Condition: |
Lung Cancer |
Interventions: |
Procedure: low-dose helical computed tomography Procedure: chest radiography |
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Recruitment was from August 2002 through April 2004 at 33 NLST sites. |
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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Participants signed a study informed consent prior to being randomized to a study arm. |
Description | |
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Low-Dose CT | Participants undergo low-dose helical CT examination. |
Chest X-ray | Participants undergo chest x-ray examination. |
Low-Dose CT | Chest X-ray | |
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STARTED | 26722 | 26732 |
COMPLETED | 26455 [1] | 26232 |
NOT COMPLETED | 267 | 500 |
Death before any screening | 2 | 5 |
Lung Cancer diagnosed before screening | 5 | 3 |
Eligible for screening but had no screen | 260 | 492 |
[1] | Had at least one screening exam. |
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Description | |
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Low-Dose CT | Participants undergo low-dose helical CT examination. |
Chest X-ray | Participants undergo chest x-ray examination. |
Low-Dose CT | Chest X-ray | Total | |
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Number of Participants
[units: participants] |
26722 | 26732 | 53454 |
Age
[units: participants] |
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<=18 years | 0 | 0 | 0 |
Between 18 and 65 years | 19612 | 19622 | 39234 |
>=65 years | 7110 | 7110 | 14220 |
Age
[units: years] Mean ± Standard Deviation |
61.4 ± 5.0 | 61.4 ± 5.0 | 61.4 ± 5.0 |
Gender
[units: participants] |
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Female | 10952 | 10970 | 21922 |
Male | 15770 | 15762 | 31532 |
Region of Enrollment
[units: participants] |
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United States | 26,722 | 26,732 | 53454 |
1. Primary: | Lung Cancer Deaths [ Time Frame: All events through December 31, 2009; median follow-up 6.5 years. ] |
2. Secondary: | Deaths From All Causes in All Randomized Participants. [ Time Frame: All events through December 31, 2009; median follow-up 6.5 years. ] |
3. Secondary: | Lung Cancer Diagnoses [ Time Frame: All events through December 31, 2009; median follow-up 6.5 years ] |
4. Secondary: | Complications of Diagnostic Evaluation Following a Positive Screening Test. [ Time Frame: One year from screening examination ] |
5. Secondary: | T0 (Baseline) Screening Results [ Time Frame: T0 (at study entry) ] |
6. Secondary: | T1 Screening Results [ Time Frame: T1 (one year after entry) ] |
7. Secondary: | T2 Screening Results [ Time Frame: T2 (two years after entry) ] |
Principal Investigators are NOT employed by the organization sponsoring the study. |
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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NLST utilized institutions with special expertise. The "healthy volunteer" effect may apply. Scanners are now more technologically advanced. Ongoing LDCT screening may reduce the rate of lung cancer deaths more than three rounds of screening. |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00047385 History of Changes |
Obsolete Identifiers: | NCT00028808 |
Other Study ID Numbers: | CDR0000257938, U01CA079778, U01CA080098, N1CN25476A-85-0-1, NIH/NCI |
Study First Received: | October 3, 2002 |
Results First Received: | May 30, 2012 |
Last Updated: | May 30, 2012 |
Health Authority: | United States: Federal Government |