Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 154,900
- Locations
- 1
- Primary Endpoint
- Colorectal Cancer Deaths
Study Overview
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 colorectal cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine whether screening with flexible sigmoidoscopy (60-cm sigmoidoscope) can reduce mortality from colorectal cancer in women and men aged 55-74 at study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 55 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
- •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
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
- •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
Arms & Interventions
Colorectal Screening
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. 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 colorectal cancers as all deaths that occur among both screened and control subjects during the trial.
Intervention: Screening Questionnaire Administration (Other)
Colorectal Screening
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. 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 colorectal cancers as all deaths that occur among both screened and control subjects during the trial.
Intervention: Sigmoidoscopy (Procedure)
Control
Participants receive standard medical care. Participants complete a DHQ at baseline.
Outcomes
Primary Outcomes
Colorectal Cancer Deaths
Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
Colorectal Cancer Death Rates
Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
Colorectal 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 Outcomes
- Deaths From All Causes(Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.)
- Colorectal Cancer Incidence Rates(Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.)
- T0 (Baseline) FSG Screening Results(T0 (at study entry))
- T3/T5 FSG Screening Result(T3 (three years after entry) or T5 (five years after entry))
- Complications of Diagnostic Evaluation Following a Positive Screening Test(One year from screening examination)
- Death Rates From All Causes(Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.)
- Colorectal Cancer Incidence(Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.)