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.

Condition	Treatment or Intervention
ovarian epithelial cancer	Procedure: annual screening  Procedure: screening intervention  Procedure: screening questionnaire

Further Study Details: 

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.

Ages Eligible for Study:  50 Years   -   74 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Other

• No concurrent participation in any other ovarian cancer screening study

Study chairs or principal investigators

Usha Menon,  Study Chair,  St. Bartholomew's Hospital   

Study ID Numbers:  CDR0000285690; UKCTOCS; EU-20249; NCT00058032
Record last reviewed:  March 2003
Last Updated:  December 6, 2004
Record first received:  April 7, 2003
ClinicalTrials.gov Identifier:  NCT00058032
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08