Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT00058032
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2003-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CA125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women
Sponsor:
University College, London
Organization:
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 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.
* 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.
Study Oversight
Has Oversight DMC:
False
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?: