CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women
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| ClinicalTrials.gov Identifier: NCT00058032 |
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Recruitment Status :
Completed
First Posted : April 9, 2003
Last Update Posted : December 4, 2013
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Ovarian Cancer | Other: screening questionnaire administration Procedure: annual screening | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Primary Purpose: | Screening |
| Official Title: | United Kingdom Collaborative Trial Of Ovarian Cancer Screening |
| Study Start Date : | February 2003 |
| Actual Study Completion Date : | March 2009 |
- Ovarian cancer mortality at 7 years post-randomization
- 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
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| Ages Eligible for Study: | 50 Years to 74 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00058032
| Study Chair: | Usha Menon, MBBS, MRCOG | St. Bartholomew's Hospital |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00058032 History of Changes |
| Other Study ID Numbers: |
CDR0000285690 UKCTOCS EU-20249 |
| First Posted: | April 9, 2003 Key Record Dates |
| Last Update Posted: | December 4, 2013 |
| Last Verified: | September 2005 |
Keywords provided by National Cancer Institute (NCI):
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ovarian epithelial cancer |
Additional relevant MeSH terms:
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Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |