CA125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women

Ovarian Cancer Clinical Trial

— UKCTOCS  

Official title:

United Kingdom Collaborative Trial Of Ovarian Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058032
• Other study ID #: CDR0000285690
• Secondary ID: UKCTOCSEU-20249
• Status: Completed
• Phase: N/A
• Start date: April 17, 2001
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202638
• Est. completion date: June 30, 2020
• Est. primary completion date: September 29, 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 74 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• screening questionnaire administration

Procedure:
• annual screening

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University College, London	Cancer Research UK, Medical Research Council, National Institute for Health Research, United Kingdom, The Eve Appeal

References & Publications (5)

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 — View Citation

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, Lees — View Citation

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, Camp — View Citation

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, S — View Citation

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 N — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UKCTOCS (2001-2014): Death due to ovarian cancer (WHO 2003) determined by independent outcomes committee review of patient notes for all women identified to have a 'possible ovarian cancer' (pre-specified ICD-10 codes) till 31st December 2014.
Primary	Long term impact of screening on ovarian cancer mortality in the UKCTOCS (LTFU UKCTOCS) (2015-2021): Death due to ovarian cancer (WHO 2014) determined by independent outcomes committee review till 30 June 2020.
Secondary	Performance characteristics: Sensitivity, specificity, positive predictive values of the two screening strategies (multimodal and ultrasound) for detection of ovarian cancer diagnosed within one year of last screen.	Ovarian cancer diagnosis is based on outcomes review of medical notes of all women who developed ovarian cancer during the trial.
Secondary	Surgical complications in women who underwent false positive surgery and were found to have benign or normal adnexae.	This is assessed through central medical note review and assigned by designated trial gynaecological oncologist.
Secondary	Cost-effectivenesss of the multimodal (MMS) and ultrasound screening (USS) strategies separately comparing them to a no-screening arm.	Cost-effectivenesss of the multimodal (MMS) and ultrasound screening (USS) strategies separately comparing them to a no-screening arm: (a) Incremental cost-effectiveness analysis over the 14 year period of the trial (censorship 31st Dec 2014); (b) Incremental cost-effectiveness analysis for the cumulative mortality estimated over a 25-year period by extrapolating beyond the 14 years of the trial
Secondary	Compliance with annual screening: The proportion of women who attended all tests that formed part of an annual screening episode of the total who were eligible for that annual screening episode.
Secondary	Psychological morbidity related to screening - assessed in a separate MRC funded study, UKCTOCS Psychosocial study, PI Prof Dame Lesley Fallowfield.