Lung Carcinoma
Conditions
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.
Interventions
Undergo questionnaire assessments
PROCEDUREX-Ray Imaging
Undergo a chest x-ray
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Cancer Deaths | 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. |
| Lung Cancer Death Rates | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung Cancer Incidence | Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. | Lung cancer diagnoses confirmed by medical record abstraction. |
| Lung Cancer Incidence Rates | Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. | 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 | One year from screening examination | Number of positive screens with complications. |
| Deaths From All Causes | Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. | Deaths from all causes were compared between the lung screening arm and the usual care arm. |
| T1 CXR Screening Results | T1 (one year after entry) | Postero-anterior view chest radiograph (CXR) result |
| T2 CXR Screening Results | T2 (two years after entry) | Postero-anterior view chest radiograph (CXR) result |
| T3 CXR Screening Results | T3 (three years after entry) | Postero-anterior view chest radiograph (CXR) result |
| T0 (Baseline) CXR Screening Results | T0 (at study entry) | Postero-anterior view chest radiograph (CXR) result |
| Death Rates From All Causes | Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years. | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Participants receive standard medical care. | 77,456 |
| 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. | 77,445 |
| Total | 154,901 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cancer Before Rand. (Lung Screening) | 0 | 8 |
| Overall Study | Died Before ASU (Control) | 278 | 0 |
| Overall Study | Died Before Randomization | 3 | 8 |
| Overall Study | Refused ASU (Control) | 920 | 0 |
| Overall Study | Refused Screen (Lung Screening) | 0 | 6,796 |
Baseline characteristics
| Characteristic | Lung Screening | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27811 Participants | 27844 Participants | 55655 Participants |
| Age, Categorical Between 18 and 65 years | 49634 Participants | 49612 Participants | 99246 Participants |
| Age, Continuous | 62.6 years STANDARD_DEVIATION 5.4 | 62.6 years STANDARD_DEVIATION 5.4 | 62.6 years STANDARD_DEVIATION 5.4 |
| Region of Enrollment United States | 77445 participants | 77456 participants | 154901 participants |
| Sex: Female, Male Female | 39105 Participants | 39111 Participants | 78216 Participants |
| Sex: Female, Male Male | 38340 Participants | 38345 Participants | 76685 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 77,445 |
| serious Total, serious adverse events | 0 / 77,445 |
Outcome results
Primary
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.
Time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Lung Cancer Death Rates | 14.2 Deaths per 10,000 PY |
| Lung Screening | Lung Cancer Death Rates | 14.0 Deaths per 10,000 PY |
95% CI: [0.91, 1.07]Poisson regression
Primary
Lung Cancer Deaths
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.
Population: All participants were analyzed. An intention-to-treat analysis was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Lung Cancer Deaths | 1230 Participants |
| Lung Screening | Lung Cancer Deaths | 1213 Participants |
95% CI: [0.91, 1.07]Poisson regression
Secondary
Complications of Diagnostic Evaluation Following a Positive Screening Test
Number of positive screens with complications.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Complications of Diagnostic Evaluation Following a Positive Screening Test | When DE Led to Lung Cancer Diagnosis | 173 Positive screens w/ complications |
| Control | Complications of Diagnostic Evaluation Following a Positive Screening Test | When DE Did Not Lead to Lung Cancer Diagnosis | 72 Positive screens w/ complications |
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Death Rates From All Causes | 128.1 Deaths per 10,000 PY |
| Lung Screening | Death Rates From All Causes | 125.3 Deaths per 10,000 PY |
95% CI: [0.95, 1]Poisson regression
Secondary
Deaths From All Causes
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.
Population: All participants were analyzed. An intention-to-treat analysis was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Deaths From All Causes | 11061 Participants |
| Lung Screening | Deaths From All Causes | 10827 Participants |
Secondary
Lung Cancer Incidence
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.
Population: All participants were analyzed. An intention-to-treat analysis was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Lung Cancer Incidence | 1620 Participants |
| Lung Screening | Lung Cancer Incidence | 1696 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Lung Cancer Incidence Rates | 19.2 Diagnoses per 10,000 PY |
| Lung Screening | Lung Cancer Incidence Rates | 20.1 Diagnoses per 10,000 PY |
95% CI: [0.98, 1.12]Poisson regression
Secondary
T0 (Baseline) CXR Screening Results
Postero-anterior view chest radiograph (CXR) result
Time frame: T0 (at study entry)
Population: All participants in the Lung Screening arm who had a CXR screen at T0 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | T0 (Baseline) CXR Screening Results | Negative | 61009 Participants |
| Control | T0 (Baseline) CXR Screening Results | Positive | 5965 Participants |
| Control | T0 (Baseline) CXR Screening Results | Inadequate screen | 63 Participants |
Secondary
T1 CXR Screening Results
Postero-anterior view chest radiograph (CXR) result
Time frame: T1 (one year after entry)
Population: All participants in the Lung Screening arm who had a CXR screen at T1 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | T1 CXR Screening Results | Negative | 60015 Participants |
| Control | T1 CXR Screening Results | Positive | 4614 Participants |
| Control | T1 CXR Screening Results | Inadequate screen | 77 Participants |
Secondary
T2 CXR Screening Results
Postero-anterior view chest radiograph (CXR) result
Time frame: T2 (two years after entry)
Population: All participants in the Lung Screening arm who had a CXR screen at T2 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | T2 CXR Screening Results | Negative | 59080 Participants |
| Control | T2 CXR Screening Results | Positive | 4157 Participants |
| Control | T2 CXR Screening Results | Inadequate screen | 68 Participants |
Secondary
T3 CXR Screening Results
Postero-anterior view chest radiograph (CXR) result
Time frame: T3 (three years after entry)
Population: All participants in the Lung Screening arm who had a CXR screen at T3 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | T3 CXR Screening Results | Negative | 38450 Participants |
| Control | T3 CXR Screening Results | Positive | 2908 Participants |
| Control | T3 CXR Screening Results | Inadequate screen | 45 Participants |