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Clinical Trials (PDQ®)

  • First Published: 3/24/2003
  • Last Modified: 2/7/2011

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Randomized Screening Study of CA 125 and Ultrasound in the Detection of Ovarian Cancer in Postmenopausal Women. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedScreeningClosed50 to 74OtherUKCTOCS
EU-20249, NCT00058032

Objectives

  1. Determine the impact of preclinical detection of ovarian cancer by screening on ovarian cancer mortality in postmenopausal women.
  2. Determine the physical morbidity of ovarian cancer screening in this population.
  3. Determine the psychological consequences of screening results (true negative, true positive, false negative, and false positive) in this population.
  4. Compare the interventions that result from screening for ovarian cancer using CA 125 monitoring and ultrasound in this population.
  5. Compare the feasibility of population screening, in terms of compliance rates with annual screening for ovarian cancer with these strategies.
  6. Compare the performance of these screening strategies in this population.

Entry Criteria

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

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

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

Expected Enrollment

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 3 years.

Outcomes

Primary Outcome(s)

Ovarian cancer mortality at 7 years post-randomization

Secondary Outcome(s)

Health economics at 7 years post-randomization
Quality of life at 7 years post-randomization
Feasibility of screening at 7 years post-randomization
Screen morbidity at 7 years post-randomization

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. 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 and 7 years after study entry.

Published Results

Jacobs I, Gentry-Maharaj A, Burnell M, et al.: Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort. Lancet Oncol 12 (1): 38-48, 2011.[PUBMED Abstract]

Menon U, Gentry-Maharaj A, Hallett R, et al.: 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 10 (4): 327-40, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Saint Bartholomew's Hospital

Usha Menon, MBBS, MRCOG, Protocol chair (Contact information may not be current)
Ph: 44-20-7882-5955
Email: u.menon@ucl.ac.uk

Registry Information
Official Title Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.United Kingdom Collaborative Trial Of Ovarian Cancer Screening
Trial Start Date 2003-02-13
Registered in ClinicalTrials.gov NCT00058032
Date Submitted to PDQ 2003-02-12
Information Last Verified 2005-09-27

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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