CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. It is not yet known if ultrasound is more effective with or without measuring CA 125 levels in detecting ovarian cancer in postmenopausal women.
PURPOSE: Randomized clinical trial to study the effectiveness of ultrasound with or without measuring CA 125 levels in detecting ovarian cancer in postmenopausal women.
Other: screening questionnaire administration
Procedure: annual screening
|Study Design:||Allocation: Randomized
Primary Purpose: Screening
|Official Title:||United Kingdom Collaborative Trial Of Ovarian Cancer Screening|
- Ovarian cancer mortality at 7 years post-randomization [ Designated as safety issue: No ]
- Health economics at 7 years post-randomization [ Designated as safety issue: No ]
- Quality of life at 7 years post-randomization [ Designated as safety issue: No ]
- Feasibility of screening at 7 years post-randomization [ Designated as safety issue: No ]
- Screen morbidity at 7 years post-randomization [ Designated as safety issue: No ]
|Study Start Date:||February 2003|
|Study Completion Date:||March 2009|
- Determine the impact of preclinical detection of ovarian cancer by screening on ovarian cancer mortality in postmenopausal women.
- Determine the physical morbidity of ovarian cancer screening in this population.
- Determine the psychological consequences of screening results (true negative, true positive, false negative, and false positive) in this population.
- Compare the interventions that result from screening for ovarian cancer using CA 125 monitoring and ultrasound in this population.
- Compare the feasibility of population screening, in terms of compliance rates with annual screening for ovarian cancer with these strategies.
- Compare the performance of these screening strategies in this population.
OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 3 screening arms.
- Arm I: Participants do not undergo screening.
- Arm II: Participants undergo screening with an annual CA 125 level. Depending on the results of the test, some patients may undergo additional screening.
- Arm III: Participants undergo screening with an annual transvaginal or transabdominal ultrasound. Depending on the results of the test, some patients may undergo additional screening.
Participants in all arms complete a health questionnaire at 3.5 and 7 years after study entry.
PROJECTED ACCRUAL: A total of 200,000 participants (100,000 for arm I and 50,000 each for arms II and III) will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058032
|Study Chair:||Usha Menon, MBBS, MRCOG||St. Bartholomew's Hospital|