Trial Outcomes & Findings for National Lung Screening Trial (NLST) Screening (NCT NCT00047385)

NCT ID: NCT00047385

Last Updated: 2014-05-20

Results Overview

Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 53454 participants
• Primary outcome timeframe: All events through December 31, 2009; median follow-up 6.5 years.
• Results posted on: 2014-05-20

Participant Flow

Recruitment was from August 2002 through April 2004 at 33 NLST sites.

Participants signed a study informed consent prior to being randomized to a study arm.

Participant milestones

Measure	Low-Dose CT Participants undergo low-dose helical CT examination.	Chest X-ray Participants undergo chest x-ray examination.
Overall Study STARTED	26722	26732
Overall Study COMPLETED	26455	26232
Overall Study NOT COMPLETED	267	500

Reasons for withdrawal

Measure	Low-Dose CT Participants undergo low-dose helical CT examination.	Chest X-ray Participants undergo chest x-ray examination.
Overall Study Death before any screening	2	5
Overall Study Lung Cancer diagnosed before screening	5	3
Overall Study Eligible for screening but had no screen	260	492

Baseline Characteristics

National Lung Screening Trial (NLST) Screening

Baseline characteristics by cohort

Measure	Low-Dose CT n=26722 Participants Participants undergo low-dose helical CT examination.	Chest X-ray n=26732 Participants Participants undergo chest x-ray examination.	Total n=53454 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19612 Participants n=5 Participants	19622 Participants n=7 Participants	39234 Participants n=5 Participants
Age, Categorical >=65 years	7110 Participants n=5 Participants	7110 Participants n=7 Participants	14220 Participants n=5 Participants
Age, Continuous	61.4 years STANDARD_DEVIATION 5.0 • n=5 Participants	61.4 years STANDARD_DEVIATION 5.0 • n=7 Participants	61.4 years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	10952 Participants n=5 Participants	10970 Participants n=7 Participants	21922 Participants n=5 Participants
Sex: Female, Male Male	15770 Participants n=5 Participants	15762 Participants n=7 Participants	31532 Participants n=5 Participants
Region of Enrollment United States	26,722 participants n=5 Participants	26,732 participants n=7 Participants	53454 participants n=5 Participants

PRIMARY outcome

Timeframe: All events through December 31, 2009; median follow-up 6.5 years.

Population: All participants randomized were analyzed. An intention-to-treat analysis was performed.

Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.

Outcome measures

Measure	LDCT Screening n=26722 Participants Participants randomized to receive three annual low-dose helical CT exams of the chest.	CXR Screening n=26732 Participants Participants randomized to receive three annual chest radiographs.
Lung Cancer Deaths	356 Participants	443 Participants

SECONDARY outcome

Timeframe: All events through December 31, 2009; median follow-up 6.5 years.

Population: All participants randomized were analyzed. An intention-to-treat analysis was performed.

Deaths from all causes were compared between the low-dose CT group and the chest radiography group among all randomized participants.

Outcome measures

Measure	LDCT Screening n=26722 Participants Participants randomized to receive three annual low-dose helical CT exams of the chest.	CXR Screening n=26732 Participants Participants randomized to receive three annual chest radiographs.
Deaths From All Causes in All Randomized Participants.	1877 Participants	2000 Participants

SECONDARY outcome

Timeframe: All events through December 31, 2009; median follow-up 6.5 years

Population: All participants randomized were analyzed. An intention-to-treat analysis was performed.

Lung cancer diagnoses confirmed by medical record abstraction.

Outcome measures

Measure	LDCT Screening n=26722 Participants Participants randomized to receive three annual low-dose helical CT exams of the chest.	CXR Screening n=26732 Participants Participants randomized to receive three annual chest radiographs.
Lung Cancer Diagnoses	1060 Participants	941 Participants

SECONDARY outcome

Timeframe: One year from screening examination

Population: The units analyzed were positive screening exams with documented diagnostic follow-up. If participant received 3 positive screens with documented follow-up after each one, he/she would be counted 3 times in the number of units analyzed.

Number of participants who experienced complications during diagnostic work-up of a screening CT or CXR that was suspicious for lung cancer.

Outcome measures

Measure	LDCT Screening n=17702 Positive Screens with Follow-up Participants randomized to receive three annual low-dose helical CT exams of the chest.	CXR Screening n=4953 Positive Screens with Follow-up Participants randomized to receive three annual chest radiographs.
Complications of Diagnostic Evaluation Following a Positive Screening Test.	245 Pos. screens w/ complications	81 Pos. screens w/ complications

SECONDARY outcome

Timeframe: T0 (at study entry)

Population: All participants randomized were analyzed.

Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.

Outcome measures

Measure	LDCT Screening n=26722 Participants Participants randomized to receive three annual low-dose helical CT exams of the chest.	CXR Screening n=26732 Participants Participants randomized to receive three annual chest radiographs.
T0 (Baseline) Screening Results Positive	7191 Participants	2387 Participants
T0 (Baseline) Screening Results Significant abnor. not suspicious for lung cancer	2695 Participants	785 Participants
T0 (Baseline) Screening Results No, or minor abnormality	16423 Participants	22863 Participants
T0 (Baseline) Screening Results Eligible but not screened	406 Participants	689 Participants
T0 (Baseline) Screening Results Not eligible for screen	7 Participants	8 Participants

SECONDARY outcome

Timeframe: T1 (one year after entry)

Population: All participants randomized were analyzed

Results of radiologist's interpretation of images from LDCT or CXR screening exam at T1. Includes a comparison with images from T0 screen.

Outcome measures

Measure	LDCT Screening n=26722 Participants Participants randomized to receive three annual low-dose helical CT exams of the chest.	CXR Screening n=26732 Participants Participants randomized to receive three annual chest radiographs.
T1 Screening Results Positive	6901 Participants	1482 Participants
T1 Screening Results Significant abnor. not suspicious for lung cancer	1519 Participants	429 Participants
T1 Screening Results No, or minor abnormality	16295 Participants	22178 Participants
T1 Screening Results Eligible but not screened	1570 Participants	2321 Participants
T1 Screening Results Not eligible for screen	437 Participants	322 Participants

SECONDARY outcome

Timeframe: T2 (two years after entry)

Population: All participants randomized were analyzed

Results of radiologist's interpretation of images from LDCT or CXR screening exam at T2. Includes a comparison with images from T0 and T1 screens.

Outcome measures

Measure	LDCT Screening n=26722 Participants Participants randomized to receive three annual low-dose helical CT exams of the chest.	CXR Screening n=26732 Participants Participants randomized to receive three annual chest radiographs.
T2 Screening Results Not eligible for screen	780 Participants	622 Participants
T2 Screening Results Positive	4054 Participants	1174 Participants
T2 Screening Results Significant abnor. not suspicious for lung cancer	1408 Participants	361 Participants
T2 Screening Results No, or minor abnormality	18640 Participants	21811 Participants
T2 Screening Results Eligible but not screened	1840 Participants	2764 Participants

Adverse Events

Low-Dose CT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chest X-ray

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Low-Dose CT n=26722 participants at risk Participants undergo low-dose helical CT examination.	Chest X-ray n=26732 participants at risk Participants undergo chest x-ray examination.
General disorders Nausea/vomiting, bradycardia, diaphoresis	0.00% 0/26722 • During each annual screening visit. These events are solely those prompted by the screening examination.	0.00% 1/26732 • Number of events 1 • During each annual screening visit. These events are solely those prompted by the screening examination.
Cardiac disorders Cardiac symptoms	0.00% 0/26722 • During each annual screening visit. These events are solely those prompted by the screening examination.	0.00% 1/26732 • Number of events 1 • During each annual screening visit. These events are solely those prompted by the screening examination.

Other adverse events

Adverse event data not reported

Additional Information

Christine D. Berg, M.D.

Early Detection Research Group, NCI, NIH

Phone: 301-496-8544

Email: bergc@mail.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60