CA125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women
NCT ID: NCT00058032
Last Updated: 2020-11-19
Study Results
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Basic Information
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COMPLETED
NA
202638 participants
INTERVENTIONAL
2001-04-17
2020-06-30
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Interventions
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screening questionnaire administration
annual screening
Eligibility Criteria
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Inclusion Criteria
* 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
50 Years
74 Years
FEMALE
Yes
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
The Eve Appeal
UNKNOWN
Medical Research Council
OTHER_GOV
Cancer Research UK
OTHER
University College, London
OTHER
Responsible Party
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Principal Investigators
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Usha Menon, MBBS, MRCOG
Role: PRINCIPAL_INVESTIGATOR
University College, London
References
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Jacobs I, Gentry-Maharaj A, Burnell M, Manchanda R, Singh N, Sharma A, Ryan A, Seif MW, Amso NN, Turner G, Brunell C, Fletcher G, Rangar R, Ford K, Godfrey K, Lopes A, Oram D, Herod J, Williamson K, Scott I, Jenkins H, Mould T, Woolas R, Murdoch J, Dobbs S, Leeson S, Cruickshank D, Skates SJ, Fallowfield L, Parmar M, Campbell S, Menon U. Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort. Lancet Oncol. 2011 Jan;12(1):38-48. doi: 10.1016/S1470-2045(10)70268-0. Epub 2010 Dec 10.
Menon U, Gentry-Maharaj A, Hallett R, Ryan A, Burnell M, Sharma A, Lewis S, Davies S, Philpott S, Lopes A, Godfrey K, Oram D, Herod J, Williamson K, Seif MW, Scott I, Mould T, Woolas R, Murdoch J, Dobbs S, Amso NN, Leeson S, Cruickshank D, McGuire A, Campbell S, Fallowfield L, Singh N, Dawnay A, Skates SJ, Parmar M, Jacobs I. Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Lancet Oncol. 2009 Apr;10(4):327-40. doi: 10.1016/S1470-2045(09)70026-9. Epub 2009 Mar 11.
Jacobs IJ, Menon U, Ryan A, Gentry-Maharaj A, Burnell M, Kalsi JK, Amso NN, Apostolidou S, Benjamin E, Cruickshank D, Crump DN, Davies SK, Dawnay A, Dobbs S, Fletcher G, Ford J, Godfrey K, Gunu R, Habib M, Hallett R, Herod J, Jenkins H, Karpinskyj C, Leeson S, Lewis SJ, Liston WR, Lopes A, Mould T, Murdoch J, Oram D, Rabideau DJ, Reynolds K, Scott I, Seif MW, Sharma A, Singh N, Taylor J, Warburton F, Widschwendter M, Williamson K, Woolas R, Fallowfield L, McGuire AJ, Campbell S, Parmar M, Skates SJ. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet. 2016 Mar 5;387(10022):945-956. doi: 10.1016/S0140-6736(15)01224-6. Epub 2015 Dec 17.
Menon U, Ryan A, Kalsi J, Gentry-Maharaj A, Dawnay A, Habib M, Apostolidou S, Singh N, Benjamin E, Burnell M, Davies S, Sharma A, Gunu R, Godfrey K, Lopes A, Oram D, Herod J, Williamson K, Seif MW, Jenkins H, Mould T, Woolas R, Murdoch JB, Dobbs S, Amso NN, Leeson S, Cruickshank D, Scott I, Fallowfield L, Widschwendter M, Reynolds K, McGuire A, Campbell S, Parmar M, Skates SJ, Jacobs I. Risk Algorithm Using Serial Biomarker Measurements Doubles the Number of Screen-Detected Cancers Compared With a Single-Threshold Rule in the United Kingdom Collaborative Trial of Ovarian Cancer Screening. J Clin Oncol. 2015 Jun 20;33(18):2062-71. doi: 10.1200/JCO.2014.59.4945. Epub 2015 May 11.
Menon U, Gentry-Maharaj A, Ryan A, Sharma A, Burnell M, Hallett R, Lewis S, Lopez A, Godfrey K, Oram D, Herod J, Williamson K, Seif M, Scott I, Mould T, Woolas R, Murdoch J, Dobbs S, Amso N, Leeson S, Cruickshank D, McGuire A, Campbell S, Fallowfield L, Skates S, Parmar M, Jacobs I. Recruitment to multicentre trials--lessons from UKCTOCS: descriptive study. BMJ. 2008 Nov 13;337:a2079. doi: 10.1136/bmj.a2079.
Dilley J, Gentry-Maharaj A, Ryan A, Burnell M, Manchanda R, Kalsi J, Singh N, Woolas R, Sharma A, Williamson K, Mould T, Fallowfield L, Campbell S, Skates SJ, McGuire A, Parmar M, Jacobs I, Menon U. Ovarian cancer symptoms in pre-clinical invasive epithelial ovarian cancer - An exploratory analysis nested within the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Gynecol Oncol. 2023 Dec;179:123-130. doi: 10.1016/j.ygyno.2023.11.005. Epub 2023 Nov 18.
Menon U, Gentry-Maharaj A, Burnell M, Apostolidou S, Ryan A, Kalsi JK, Singh N, Fallowfield L, McGuire AJ, Campbell S, Skates SJ, Dawnay A, Parmar M, Jacobs IJ; UKCTOCS team. Insights from UKCTOCS for design, conduct and analyses of large randomised controlled trials. Health Technol Assess. 2023 Aug;29(10):1-48. doi: 10.3310/CLDC7214.
Menon U, Gentry-Maharaj A, Burnell M, Ryan A, Singh N, Manchanda R, Kalsi JK, Woolas R, Arora R, Casey L, Dawnay A, Sharma A, Williamson K, Apostolidou S, Fallowfield L, McGuire AJ, Campbell S, Skates SJ, Jacobs IJ, Parmar MKB. Tumour stage, treatment, and survival of women with high-grade serous tubo-ovarian cancer in UKCTOCS: an exploratory analysis of a randomised controlled trial. Lancet Oncol. 2023 Sep;24(9):1018-1028. doi: 10.1016/S1470-2045(23)00335-2.
Menon U, Gentry-Maharaj A, Burnell M, Singh N, Ryan A, Karpinskyj C, Carlino G, Taylor J, Massingham SK, Raikou M, Kalsi JK, Woolas R, Manchanda R, Arora R, Casey L, Dawnay A, Dobbs S, Leeson S, Mould T, Seif MW, Sharma A, Williamson K, Liu Y, Fallowfield L, McGuire AJ, Campbell S, Skates SJ, Jacobs IJ, Parmar M. Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet. 2021 Jun 5;397(10290):2182-2193. doi: 10.1016/S0140-6736(21)00731-5. Epub 2021 May 12.
Russell MR, Graham C, D'Amato A, Gentry-Maharaj A, Ryan A, Kalsi JK, Whetton AD, Menon U, Jacobs I, Graham RLJ. Diagnosis of epithelial ovarian cancer using a combined protein biomarker panel. Br J Cancer. 2019 Sep;121(6):483-489. doi: 10.1038/s41416-019-0544-0. Epub 2019 Aug 7.
Fraser L, Burnell M, Salter LC, Fourkala EO, Kalsi J, Ryan A, Gessler S, Gidron Y, Steptoe A, Menon U. Identifying hopelessness in population research: a validation study of two brief measures of hopelessness. BMJ Open. 2014 May 30;4(5):e005093. doi: 10.1136/bmjopen-2014-005093.
Other Identifiers
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UKCTOCS
Identifier Type: -
Identifier Source: secondary_id
EU-20249
Identifier Type: -
Identifier Source: secondary_id
CDR0000285690
Identifier Type: -
Identifier Source: org_study_id