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Trial record 3 of 4 for:    PLCO-1

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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants signed a study informed consent prior to being randomized to a study arm.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Control   Lung Screening
STARTED   77456   77445 
COMPLETED   76255   70633 
NOT COMPLETED   1201   6812 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control 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.
Total Total of all reporting groups

Baseline Measures
   Control   Lung Screening   Total 
Overall Participants Analyzed 
[Units: Participants]
 77456   77445   154901 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 62.6  (5.4)   62.6  (5.4)   62.6  (5.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      39111  50.5%      39105  50.5%      78216  50.5% 
Male      38345  49.5%      38340  49.5%      76685  49.5% 
Region of Enrollment 
[Units: Participants]
     
United States   77456   77445   154901 


  Outcome Measures

1.  Primary:   Lung Cancer Deaths   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]

2.  Primary:   Lung Cancer Death Rates   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]

3.  Secondary:   Deaths From All Causes   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]

4.  Secondary:   Death Rates From All Causes   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]

5.  Secondary:   Lung Cancer Incidence   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]

6.  Secondary:   Lung Cancer Incidence Rates   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ]

7.  Secondary:   Complications of Diagnostic Evaluation Following a Positive Screening Test   [ Time Frame: One year from screening examination ]

8.  Secondary:   T0 (Baseline) CXR Screening Results   [ Time Frame: T0 (at study entry) ]

9.  Secondary:   T1 CXR Screening Results   [ Time Frame: T1 (one year after entry) ]

10.  Secondary:   T2 CXR Screening Results   [ Time Frame: T2 (two years after entry) ]

11.  Secondary:   T3 CXR Screening Results   [ Time Frame: T3 (three years after entry) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: pinskyp@mail.nih.gov



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