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

Primary Purpose

Lung Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening Questionnaire Administration
X-Ray Imaging
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Carcinoma

Eligibility Criteria

55 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Exclusion Criteria:

  • 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

Sites / Locations

  • National Institutes of Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Lung Screening

Arm Description

Participants receive standard medical care. Participants complete a DHQ at baseline.

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.

Outcomes

Primary Outcome Measures

Lung Cancer Deaths
Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
Lung Cancer Death Rates
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
Deaths from all causes were compared between the lung screening arm and the usual care arm.
Death Rates From All Causes
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
Lung cancer diagnoses confirmed by medical record abstraction.
Lung Cancer Incidence Rates
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
Number of positive screens with complications.
T0 (Baseline) CXR Screening Results
Postero-anterior view chest radiograph (CXR) result
T1 CXR Screening Results
Postero-anterior view chest radiograph (CXR) result
T2 CXR Screening Results
Postero-anterior view chest radiograph (CXR) result
T3 CXR Screening Results
Postero-anterior view chest radiograph (CXR) result

Full Information

First Posted
September 28, 2012
Last Updated
April 25, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01696968
Brief Title
Screening for Lung Cancer in Older Patients (PLCO Screening Trial)
Official Title
Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 16, 1993 (Actual)
Primary Completion Date
May 21, 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for lung cancer.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
154901 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants receive standard medical care. Participants complete a DHQ at baseline.
Arm Title
Lung Screening
Arm Type
Active Comparator
Arm 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. 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.
Intervention Type
Other
Intervention Name(s)
Screening Questionnaire Administration
Intervention Description
Undergo questionnaire assessments
Intervention Type
Procedure
Intervention Name(s)
X-Ray Imaging
Other Intervention Name(s)
Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs, Radiographic Imaging, Radiographic imaging procedure (procedure), Radiography, RG, Static X-Ray, X-Ray
Intervention Description
Undergo a chest x-ray
Primary Outcome Measure Information:
Title
Lung Cancer Deaths
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.
Title
Lung Cancer Death Rates
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.
Secondary Outcome Measure Information:
Title
Deaths From All Causes
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.
Title
Death Rates From All Causes
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.
Title
Lung Cancer Incidence
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.
Title
Lung Cancer Incidence Rates
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.
Title
Complications of Diagnostic Evaluation Following a Positive Screening Test
Description
Number of positive screens with complications.
Time Frame
One year from screening examination
Title
T0 (Baseline) CXR Screening Results
Description
Postero-anterior view chest radiograph (CXR) result
Time Frame
T0 (at study entry)
Title
T1 CXR Screening Results
Description
Postero-anterior view chest radiograph (CXR) result
Time Frame
T1 (one year after entry)
Title
T2 CXR Screening Results
Description
Postero-anterior view chest radiograph (CXR) result
Time Frame
T2 (two years after entry)
Title
T3 CXR Screening Results
Description
Postero-anterior view chest radiograph (CXR) result
Time Frame
T3 (three years after entry)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine D Berg
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35658861
Citation
You D, Wang D, Wu Y, Chen X, Shao F, Wei Y, Zhang R, Lange T, Ma H, Xu H, Hu Z, Christiani DC, Shen H, Chen F, Zhao Y. Associations of genetic risk, BMI trajectories, and the risk of non-small cell lung cancer: a population-based cohort study. BMC Med. 2022 Jun 6;20(1):203. doi: 10.1186/s12916-022-02400-6.
Results Reference
derived
PubMed Identifier
34548240
Citation
Jiang Y, Xie Q, Chen R. Breast Cancer Incidence and Mortality in Relation to Hormone Replacement Therapy Use Among Postmenopausal Women: Results From a Prospective Cohort Study. Clin Breast Cancer. 2022 Feb;22(2):e206-e213. doi: 10.1016/j.clbc.2021.06.010. Epub 2021 Jun 26.
Results Reference
derived
PubMed Identifier
33277073
Citation
Wang K, Wu Q, Li Z, Reger MK, Xiong Y, Zhong G, Li Q, Zhang X, Li H, Foukakis T, Xiang T, Zhang J, Ren G. Vitamin K intake and breast cancer incidence and death: results from a prospective cohort study. Clin Nutr. 2021 May;40(5):3370-3378. doi: 10.1016/j.clnu.2020.11.009. Epub 2020 Nov 16.
Results Reference
derived

Learn more about this trial

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

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