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Trial record 3 of 4 for:    PLCO-1

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01696968
Recruitment Status : Active, not recruiting
First Posted : October 2, 2012
Results First Posted : July 21, 2014
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Screening
Condition Lung Carcinoma
Interventions Other: Screening Questionnaire Administration
Procedure: X-Ray Imaging
Enrollment 154901
Recruitment Details 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).
Pre-assignment Details Participants signed a study informed consent prior to being randomized to a study arm.
Arm/Group Title Control Lung Screening
Hide Arm/Group Description Participants receive standard medical care. 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.
Period Title: Overall Study
Started 77456 77445
Completed 76255 70633
Not Completed 1201 6812
Reason Not Completed
Cancer Before Rand. (Lung Screening)             0             8
Died Before Randomization             3             8
Died Before ASU (Control)             278             0
Refused ASU (Control)             920             0
Refused Screen (Lung Screening)             0             6796
Arm/Group Title Control Lung Screening Total
Hide Arm/Group Description Participants receive standard medical care. 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 of all reporting groups
Overall Number of Baseline Participants 77456 77445 154901
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77456 participants 77445 participants 154901 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
49612
  64.1%
49634
  64.1%
99246
  64.1%
>=65 years
27844
  35.9%
27811
  35.9%
55655
  35.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77456 participants 77445 participants 154901 participants
62.6  (5.4) 62.6  (5.4) 62.6  (5.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77456 participants 77445 participants 154901 participants
Female
39111
  50.5%
39105
  50.5%
78216
  50.5%
Male
38345
  49.5%
38340
  49.5%
76685
  49.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 77456 participants 77445 participants 154901 participants
77456 77445 154901
1.Primary Outcome
Title Lung Cancer Deaths
Hide Description Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title Control Lung Screening
Hide Arm/Group Description:
Participants receive standard medical care.
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.
Overall Number of Participants Analyzed 77456 77445
Measure Type: Number
Unit of Measure: Participants
1230 1213
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Lung Screening
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.91 to 1.07
Estimation Comments [Not Specified]
2.Primary Outcome
Title Lung Cancer Death Rates
Hide Description 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.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Lung Screening
Hide Arm/Group Description:
Participants receive standard medical care.
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 Number of Participants Analyzed 77456 77445
Measure Type: Number
Unit of Measure: Deaths per 10,000 PY
14.2 14.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Lung Screening
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.91 to 1.07
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Deaths From All Causes
Hide Description Deaths from all causes were compared between the lung screening arm and the usual care arm.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title Control Lung Screening
Hide Arm/Group Description:
Participants receive standard medical care.
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 Number of Participants Analyzed 77456 77445
Measure Type: Number
Unit of Measure: Participants
11061 10827
4.Secondary Outcome
Title Death Rates From All Causes
Hide Description 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.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title Control Lung Screening
Hide Arm/Group Description:
Participants receive standard medical care.
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.
Overall Number of Participants Analyzed 77456 77445
Measure Type: Number
Unit of Measure: Deaths per 10,000 PY
128.1 125.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Lung Screening
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.95 to 1.00
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Lung Cancer Incidence
Hide Description Lung cancer diagnoses confirmed by medical record abstraction.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title Control Lung Screening
Hide Arm/Group Description:
Participants receive standard medical care.
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 Number of Participants Analyzed 77456 77445
Measure Type: Number
Unit of Measure: Participants
1620 1696
6.Secondary Outcome
Title Lung Cancer Incidence Rates
Hide Description 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.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title Control Lung Screening
Hide Arm/Group Description:
Participants receive standard medical care.
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.
Overall Number of Participants Analyzed 77456 77445
Measure Type: Number
Unit of Measure: Diagnoses per 10,000 PY
19.2 20.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Lung Screening
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.98 to 1.12
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Complications of Diagnostic Evaluation Following a Positive Screening Test
Hide Description Number of positive screens with complications.
Time Frame One year from screening examination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lung Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12889
Overall Number of Units Analyzed
Type of Units Analyzed: Positive Screens with Follow-up
17475
Measure Type: Number
Unit of Measure: Positive screens w/ complications
When DE Led to Lung Cancer Diagnosis 173
When DE Did Not Lead to Lung Cancer Diagnosis 72
8.Secondary Outcome
Title T0 (Baseline) CXR Screening Results
Hide Description Postero-anterior view chest radiograph (CXR) result
Time Frame T0 (at study entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the Lung Screening arm who had a CXR screen at T0 were analyzed.
Arm/Group Title Lung Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 67037
Measure Type: Number
Unit of Measure: Participants
Negative 61009
Positive 5965
Inadequate screen 63
9.Secondary Outcome
Title T1 CXR Screening Results
Hide Description Postero-anterior view chest radiograph (CXR) result
Time Frame T1 (one year after entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the Lung Screening arm who had a CXR screen at T1 were analyzed.
Arm/Group Title Lung Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 64706
Measure Type: Number
Unit of Measure: Participants
Negative 60015
Positive 4614
Inadequate screen 77
10.Secondary Outcome
Title T2 CXR Screening Results
Hide Description Postero-anterior view chest radiograph (CXR) result
Time Frame T2 (two years after entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the Lung Screening arm who had a CXR screen at T2 were analyzed.
Arm/Group Title Lung Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 63305
Measure Type: Number
Unit of Measure: Participants
Negative 59080
Positive 4157
Inadequate screen 68
11.Secondary Outcome
Title T3 CXR Screening Results
Hide Description Postero-anterior view chest radiograph (CXR) result
Time Frame T3 (three years after entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in the Lung Screening arm who had a CXR screen at T3 were analyzed.
Arm/Group Title Lung Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 41403
Measure Type: Number
Unit of Measure: Participants
Negative 38450
Positive 2908
Inadequate screen 45
Time Frame During each annual screening visit.
Adverse Event Reporting Description These events are solely those prompted by the screening examination.
 
Arm/Group Title Lung Screening
Hide Arm/Group Description 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.
All-Cause Mortality
Lung Screening
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lung Screening
Affected / at Risk (%)
Total   0/77445 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Lung Screening
Affected / at Risk (%)
Total   0/77445 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Name/Title: Paul F. Pinsky, Ph.D.
Organization: Early Detection Research Group, NCI, NIH
Phone: 301-496-8544
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01696968     History of Changes
Other Study ID Numbers: NCI-2012-01756
NCI-2012-01756 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PLCO-1
CDR0000078532
NCI-P93-0050
PLCO-Lung ( Other Identifier: National Institutes of Health Clinical Center )
First Submitted: September 28, 2012
First Posted: October 2, 2012
Results First Submitted: August 30, 2013
Results First Posted: July 21, 2014
Last Update Posted: February 15, 2018