Trial Information

United Kingdom Collaborative Trial Of Ovarian Cancer Screening

OBJECTIVES:

- 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.