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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01696968
First received: September 28, 2012
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

This results record (NCT01696968) addresses whether lung cancer screening tests reduce lung cancer mortality by helping doctors find cancer cells early and plan better treatment for lung cancer. The lung cancer screening tests are part of a trial that addresses the screening of four cancer sites, each with their own results record: prostate (NCT00002540), lung (NCT01696968), colorectal (NCT01696981), and ovarian (NCT01696994).


Condition Intervention
Lung Cancer
Procedure: radiography
Other: screening questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
Official Title: Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Lung Cancer Deaths [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ] [ Designated as safety issue: No ]
    Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.

  • Lung Cancer Death Rates [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Deaths From All Causes [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ] [ Designated as safety issue: No ]
    Deaths from all causes were compared between the lung screening arm and the usual care arm.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • Lung Cancer Incidence [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ] [ Designated as safety issue: No ]
    Lung cancer diagnoses confirmed by medical record abstraction.

  • Lung Cancer Incidence Rates [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. ] [ Designated as safety issue: No ]
    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.

  • Complications of Diagnostic Evaluation Following a Positive Screening Test [ Time Frame: One year from screening examination ] [ Designated as safety issue: Yes ]
    Number of positive screens with complications.

  • T0 (Baseline) CXR Screening Results [ Time Frame: T0 (at study entry) ] [ Designated as safety issue: No ]
    Postero-anterior view chest radiograph (CXR) result

  • T1 CXR Screening Results [ Time Frame: T1 (one year after entry) ] [ Designated as safety issue: No ]
    Postero-anterior view chest radiograph (CXR) result

  • T2 CXR Screening Results [ Time Frame: T2 (two years after entry) ] [ Designated as safety issue: No ]
    Postero-anterior view chest radiograph (CXR) result

  • T3 CXR Screening Results [ Time Frame: T3 (three years after entry) ] [ Designated as safety issue: No ]
    Postero-anterior view chest radiograph (CXR) result


Enrollment: 154901
Study Start Date: November 1993
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Participants receive standard medical care. Participants complete a DHQ at baseline.
Active Comparator: 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. Participants complete a BQF/M at baseline. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident lung cancers as all deaths that occur among both screened and control subjects during the trial.
Procedure: radiography
Undergo a chest x-ray
Other: screening questionnaire administration
Undergo questionnaire assessments

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine whether screening with chest x-ray can reduce mortality from lung cancer in women and men aged 55-74 at entry.

SECONDARY OBJECTIVES:

I. To assess screening variables, other than mortality, for each of the interventions including sensitivity, specificity, and positive predictive value.

II. To assess the incidence, stage, and survival of cancer cases. III. To investigate the mortality predictive value of biologic and/or prognostic characterizations of tumor tissue as intermediate endpoints.

IV. To conduct biomolecular and genetic research into factors associated with cancer carcinogenesis and promotion, as well as the early detection of these factors.

OUTLINE: Participants in the overall PLCO study are stratified by screening center, gender, and age (55-59 vs 60-64 vs 65-69 vs 70-74). Participants are randomized to 1 of 2 arms (control vs screening).

ARM I (Control): Participants receive standard medical care. Participants complete a Diet History Questionnaire (DHQ) at baseline.

ARM II (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. A scheduling and tracking procedure is implemented to ensure regular attendance at repeat screens for participants screened negative or for those who are designated suspicious or positive at screening but for whom subsequent diagnostic procedures do not reveal lung cancer (follow-up diagnostic procedures are through their own medical care environment). Participants diagnosed with lung cancer via a screening test are referred for treatment in accordance with current accepted practice for appropriate stage of disease, patient age, and medical condition; a procedure is provided for contact with qualified medical personnel to insure appropriate therapy.

Participants complete a Baseline Questionnaire (BQF/M) to assess smoking status. Participants complete a Dietary Questionnaire (DQX) at baseline and DHQ at year 3. An Annual Study Update (ADU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident lung cancers as all deaths that occur among both screened and control subjects during the trial.

After completion of screening, participants are followed up for at least 13 years.

  Eligibility

Ages Eligible for Study:   55 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria (the following criteria are applied to all participants in the study, all of whom are also included in the colorectal outcome. All men are included in the prostate outcome and women in the ovarian outcome):

  • Men and women who at the time of randomization are less than 55 or greater than or equal to 75 years of age
  • Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer
  • Individuals with known prior cancer of the colon, rectum, lung, prostate (men only) or ovary (women only)

    • This includes primary or metastatic PLCO cancers
  • Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate (men only)

    • Until October 1996, women with previous surgical removal of both ovaries were excluded from the trial. In order to increase the enrollment of women into the trial, beginning in October 1996, these women were no longer excluded for this reason.
  • Individuals who are participating in another cancer screening or cancer primary prevention trial
  • Males who have taken Proscar/Propecia/finasteride in the past 6 months

    • NOTE: Individuals who are already enrolled in the trial when their physician prescribes finasteride are not prevented from taking this medication. As a result, these participants will continue to be screened and followed just as those participants who are not on finasteride.
    • NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO Screening Trial.
    • Prior to April 1, 1999 women were excluded from the trial if they were currently taking or had taken Tamoxifen or Evista\Raloxifene in the past 6 months. As of April 1999 based on a decision from the PLCO Ovary Subcommittee, women who have or are currently taking Tamoxifen or Evista\Raloxifene are not excluded from participation.
  • Individuals who are unwilling or unable to sign the informed consent form
  • Males who have had more than one PSA blood test in the past three years
  • Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696968

Locations
United States, Maryland
Mark O Hatfield-Warren Grant Magnuson Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Christine Berg Mark O Hatfield-Warren Grant Magnuson Clinical Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01696968     History of Changes
Other Study ID Numbers: NCI-2012-01756, NCI-2012-01756, PLCO-1, CDR0000078532, NCI-P93-0050, PLCO-Lung
Study First Received: September 28, 2012
Results First Received: August 30, 2013
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014