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Trial record 1 of 1 for:    UKCTOCS
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CA125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women (UKCTOCS)

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ClinicalTrials.gov Identifier: NCT00058032
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : November 19, 2020
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
The Eve Appeal
Medical Research Council
Cancer Research UK
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE April 7, 2003
First Posted Date  ICMJE April 9, 2003
Last Update Posted Date November 19, 2020
Actual Study Start Date  ICMJE April 17, 2001
Actual Primary Completion Date September 29, 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2020)
  • 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.
  • 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.
  • 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
  • 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.
  • Psychological morbidity related to screening - assessed in a separate MRC funded study, UKCTOCS Psychosocial study, PI Prof Dame Lesley Fallowfield.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CA125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women
Official Title  ICMJE United Kingdom Collaborative Trial Of Ovarian Cancer Screening
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
202,638 participants randomised to: Multimodal Group: 50640 Ultrasound Group: 50639 Control Group: 101359
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Other: screening questionnaire administration
  • Procedure: annual screening
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2020)
202638
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date September 29, 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00058032
Other Study ID Numbers  ICMJE CDR0000285690
UKCTOCS
EU-20249
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE
  • National Institute for Health Research, United Kingdom
  • The Eve Appeal
  • Medical Research Council
  • Cancer Research UK
Investigators  ICMJE
Principal Investigator: Usha Menon, MBBS, MRCOG University College, London
PRS Account University College, London
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP