CA125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women (UKCTOCS)

University College London (UCL)

Status

Completed

Conditions

Ovarian Cancer

Treatments

Procedure: annual screening

Other: screening questionnaire administration

Study type

Interventional

Funder types

Other

Identifiers

NCT00058032

UKCTOCS

CDR0000285690

EU-20249

Details and patient eligibility

About

RATIONALE: Screening tests may help doctors detect ovarian cancer early when the survival is much more encouraging. It is not yet known whether a CA125-based or ultrasound strategy is more effective in detecting ovarian cancer early thereby impacting on the mortality from the disease in postmenopausal women from the general population.

PURPOSE: Randomized clinical trial to assess the impact of screening using a multimodal strategy using CA125 interpreted by the Risk of Ovarian Cancer Algorithm (ROCA) followed by transvaginal ultrasound as a second line test versus transvaginal ultrasound on mortality from the disease in postmenopausal women from the general population.

Full description

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 interpreted using the Risk of Ovarian Cancer Algorithm (ROCA). 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 years after study entry and in 2014.

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 5 years.

Enrollment

202,638 patients

Sex

Female

Ages

50 to 74 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Postmenopausal, as defined by meeting 1 of the following criteria:
- More than 12 months of amenorrhea after natural menopause or hysterectomy
- Received more than 12 months of hormone replacement therapy for menopausal symptoms
No prior ovarian malignancy
No prior bilateral oophorectomy
Not at high risk for ovarian cancer due to familial predisposition as defined by the UKCCCR Familial Ovarian Cancer Screening Study

PATIENT CHARACTERISTICS:

Age

50 to 74

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No active non-ovarian malignancy
- Prior malignancy allowed provided there is no documented persistent or recurrent disease and patient has not received treatment for more than 1 year

PRIOR CONCURRENT THERAPY:

Biologic therapy