Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058032
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2003-04-07
Brief Title:
CA125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
United Kingdom Collaborative Trial Of Ovarian Cancer Screening
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UKCTOCS
Brief Summary:
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
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:
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 200000 participants 100000 for arm I and 50000 each for arms II and III will be accrued for this study within 5 years
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 200000 participants 100000 for arm I and 50000 each for arms II and III will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20249 | None | None | None |
| UKCTOCS | None | None | None |