Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 78,216
- Locations
- 2
- Primary Endpoint
- Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)
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 ovarian cancer. The ovarian 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).
Detailed Description
PRIMARY OBJECTIVES:
I. To determine whether screening with CA125 and transvaginal ultrasound (TVU) can reduce mortality from ovarian cancer in women 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.
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
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Exclusion Criteria:
- •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, or ovary
- •This includes primary or metastatic PLCO cancers
- •Individuals with previous surgical removal of the entire colon or one lung
- •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
- •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
- •Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years
Exclusion Criteria
- •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, or ovary
- •This includes primary or metastatic PLCO cancers
- •Individuals with previous surgical removal of the entire colon or one lung
- •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
- •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
- •Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years
Arms & Interventions
Control
Participants receive standard medical care. Participants complete a DHQ at baseline.
Ovarian Screening
Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years. 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 cancers of the ovaries as all deaths that occur among both screened and control subjects during the trial.
Intervention: Laboratory Biomarker Analysis (Other)
Ovarian Screening
Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years. 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 cancers of the ovaries as all deaths that occur among both screened and control subjects during the trial.
Intervention: Screening Questionnaire Administration (Other)
Ovarian Screening
Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years. 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 cancers of the ovaries as all deaths that occur among both screened and control subjects during the trial.
Intervention: Ultrasound Imaging (Procedure)
Outcomes
Primary Outcomes
Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)
Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
Ovarian Cancer Death Rates (Including Primary Peritoneal and Fallopian Tube Cancers)
Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
Ovarian 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
- T5 CA-125 Screening Results(T5 (five years after entry))
- Death Rates From All Causes(Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.)
- Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test(One year from screening examination)
- T1 CA-125 Screening Results(T1 (one year after entry))
- T4 CA-125 Screening Results(T4 (four years after entry))
- T3 TVU Screening Results(T3 (three years after entry))
- T1 TVU Screening Results(T1 (one year after entry))
- T0 (Baseline) CA-125 Screening Results(T0 (at study entry))
- T0 (Baseline) TVU Screening Results(T0 (at study entry))
- T2 CA-125 Screening Results(T2 (two years after entry))
- T2 TVU Screening Results(T2 (one year after entry))
- Deaths From All Causes(Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.)
- T3 CA-125 Screening Results(T3 (three years after entry))
- Ovarian Cancer Incidence (Including Primary Peritoneal and Fallopian Tube Cancers)(Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.)
- Ovarian Cancer Incidence Rates (Including Primary Peritoneal and Fallopian Tube Cancers).(Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.)