Trial Outcomes & Findings for Screening for Lung Cancer in Older Patients (PLCO Screening Trial) (NCT NCT01696968)

NCT ID: NCT01696968

Last Updated: 2025-07-23

Results Overview

Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 154901 participants
• Primary outcome timeframe: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
• Results posted on: 2025-07-23

Participant Flow

Participants were enrolled between November 1993 and July 2001 at 10 study centers. Recruitment was done for all four outcomes of the study (prostate, lung, colorectal and ovarian).

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

Participant milestones

Measure	Control Participants receive standard medical care.	Lung Screening Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
Overall Study STARTED	77456	77445
Overall Study COMPLETED	76255	70633
Overall Study NOT COMPLETED	1201	6812

Reasons for withdrawal

Measure	Control Participants receive standard medical care.	Lung Screening Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
Overall Study Cancer Before Rand. (Lung Screening)	0	8
Overall Study Died Before Randomization	3	8
Overall Study Died Before ASU (Control)	278	0
Overall Study Refused ASU (Control)	920	0
Overall Study Refused Screen (Lung Screening)	0	6796

Baseline Characteristics

Screening for Lung Cancer in Older Patients (PLCO Screening Trial)

Baseline characteristics by cohort

Measure	Control n=77456 Participants Participants receive standard medical care.	Lung Screening n=77445 Participants Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.	Total n=154901 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	49612 Participants n=5 Participants	49634 Participants n=7 Participants	99246 Participants n=5 Participants
Age, Categorical >=65 years	27844 Participants n=5 Participants	27811 Participants n=7 Participants	55655 Participants n=5 Participants
Age, Continuous	62.6 years STANDARD_DEVIATION 5.4 • n=5 Participants	62.6 years STANDARD_DEVIATION 5.4 • n=7 Participants	62.6 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	39111 Participants n=5 Participants	39105 Participants n=7 Participants	78216 Participants n=5 Participants
Sex: Female, Male Male	38345 Participants n=5 Participants	38340 Participants n=7 Participants	76685 Participants n=5 Participants
Region of Enrollment United States	77456 participants n=5 Participants	77445 participants n=7 Participants	154901 participants n=5 Participants

PRIMARY outcome

Timeframe: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.

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

Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.

Outcome measures

Measure	Control n=77456 Participants Participants receive standard medical care.	Lung Screening n=77445 Participants Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
Lung Cancer Deaths	1230 Participants	1213 Participants

PRIMARY outcome

Timeframe: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.

Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.

Outcome measures

Measure	Control n=77456 Participants Participants receive standard medical care.	Lung Screening n=77445 Participants Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
Lung Cancer Death Rates	14.2 Deaths per 10,000 PY	14.0 Deaths per 10,000 PY

SECONDARY outcome

Timeframe: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.

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

Deaths from all causes were compared between the lung screening arm and the usual care arm.

Outcome measures

Measure	Control n=77456 Participants Participants receive standard medical care.	Lung Screening n=77445 Participants Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
Deaths From All Causes	11061 Participants	10827 Participants

SECONDARY outcome

Timeframe: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.

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

Deaths from all causes were compared between the lung screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.

Outcome measures

Measure	Control n=77456 Participants Participants receive standard medical care.	Lung Screening n=77445 Participants Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
Death Rates From All Causes	128.1 Deaths per 10,000 PY	125.3 Deaths per 10,000 PY

SECONDARY outcome

Timeframe: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.

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

Lung cancer diagnoses confirmed by medical record abstraction.

Outcome measures

Measure	Control n=77456 Participants Participants receive standard medical care.	Lung Screening n=77445 Participants Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
Lung Cancer Incidence	1620 Participants	1696 Participants

SECONDARY outcome

Timeframe: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.

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

Lung cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as lung cancer diagnoses divided by person years at risk for lung cancer.

Outcome measures

Measure	Control n=77456 Participants Participants receive standard medical care.	Lung Screening n=77445 Participants Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
Lung Cancer Incidence Rates	19.2 Diagnoses per 10,000 PY	20.1 Diagnoses per 10,000 PY

SECONDARY outcome

Timeframe: One year from screening examination

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

Number of positive screens with complications.

Outcome measures

Measure	Control n=17475 Positive Screens with Follow-up Participants receive standard medical care.	Lung Screening Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
Complications of Diagnostic Evaluation Following a Positive Screening Test When DE Led to Lung Cancer Diagnosis	173 Positive screens w/ complications	—
Complications of Diagnostic Evaluation Following a Positive Screening Test When DE Did Not Lead to Lung Cancer Diagnosis	72 Positive screens w/ complications	—

SECONDARY outcome

Timeframe: T0 (at study entry)

Population: All participants in the Lung Screening arm who had a CXR screen at T0 were analyzed.

Postero-anterior view chest radiograph (CXR) result

Outcome measures

Measure	Control n=67037 Participants Participants receive standard medical care.	Lung Screening Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
T0 (Baseline) CXR Screening Results Negative	61009 Participants	—
T0 (Baseline) CXR Screening Results Positive	5965 Participants	—
T0 (Baseline) CXR Screening Results Inadequate screen	63 Participants	—

SECONDARY outcome

Timeframe: T1 (one year after entry)

Population: All participants in the Lung Screening arm who had a CXR screen at T1 were analyzed.

Postero-anterior view chest radiograph (CXR) result

Outcome measures

Measure	Control n=64706 Participants Participants receive standard medical care.	Lung Screening Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
T1 CXR Screening Results Negative	60015 Participants	—
T1 CXR Screening Results Positive	4614 Participants	—
T1 CXR Screening Results Inadequate screen	77 Participants	—

SECONDARY outcome

Timeframe: T2 (two years after entry)

Population: All participants in the Lung Screening arm who had a CXR screen at T2 were analyzed.

Postero-anterior view chest radiograph (CXR) result

Outcome measures

Measure	Control n=63305 Participants Participants receive standard medical care.	Lung Screening Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
T2 CXR Screening Results Negative	59080 Participants	—
T2 CXR Screening Results Positive	4157 Participants	—
T2 CXR Screening Results Inadequate screen	68 Participants	—

SECONDARY outcome

Timeframe: T3 (three years after entry)

Population: All participants in the Lung Screening arm who had a CXR screen at T3 were analyzed.

Postero-anterior view chest radiograph (CXR) result

Outcome measures

Measure	Control n=41403 Participants Participants receive standard medical care.	Lung Screening Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.
T3 CXR Screening Results Negative	38450 Participants	—
T3 CXR Screening Results Positive	2908 Participants	—
T3 CXR Screening Results Inadequate screen	45 Participants	—

Adverse Events

Lung Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul F. Pinsky, Ph.D.

Early Detection Research Group, NCI, NIH

Phone: 301-496-8544

Email: pinskyp@mail.nih.gov

Results disclosure agreements

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

Restriction type: LTE60