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Randomized Screening Study of CA 125 and Ultrasound in the Detection of Ovarian Cancer in Postmenopausal Women
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women
Basic Trial Information
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Protocol IDs
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No phase specified
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Screening
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Closed
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50 to 74
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Other
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UKCTOCS
EU-20249, NCT00058032
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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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy - See Disease Characteristics
Radiotherapy Surgery - See Disease Characteristics
Other - No concurrent participation in any other ovarian cancer screening study
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal 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
Expected Enrollment 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. Outcomes Primary Outcome(s)Ovarian cancer mortality at 7 years post-randomization
Secondary Outcome(s)Health economics at 7 years post-randomization
Quality of life at 7 years post-randomization
Feasibility of screening at 7 years post-randomization
Screen morbidity at 7 years post-randomization
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.
Trial Contact Information
Trial Lead Organizations Saint Bartholomew's Hospital | | | | Usha Menon, MBBS, MRCOG, Protocol chair(Contact information may not be current) | | | |
| Registry Information | | | Official Title | | United Kingdom Collaborative Trial Of Ovarian Cancer Screening | | | Trial Start Date | | 2003-02-13 | | | Registered in ClinicalTrials.gov | | NCT00058032 | | | Date Submitted to PDQ | | 2003-02-12 | | | Information Last Verified | | 2005-09-27 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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