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Trial record 1 of 1 for:    UKCTOCS
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CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00058032
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : December 4, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. It is not yet known if ultrasound is more effective with or without measuring CA 125 levels in detecting ovarian cancer in postmenopausal women.

PURPOSE: Randomized clinical trial to study the effectiveness of ultrasound with or without measuring CA 125 levels in detecting ovarian cancer in postmenopausal women.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Other: screening questionnaire administration Procedure: annual screening Not Applicable

Detailed Description:


  • 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. 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.

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 3 years.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Screening
Official Title: United Kingdom Collaborative Trial Of Ovarian Cancer Screening
Study Start Date : February 2003
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Primary Outcome Measures :
  1. Ovarian cancer mortality at 7 years post-randomization

Secondary Outcome Measures :
  1. Health economics at 7 years post-randomization
  2. Quality of life at 7 years post-randomization
  3. Feasibility of screening at 7 years post-randomization
  4. Screen morbidity at 7 years post-randomization

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes


  • 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



  • 50 to 74

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • See Disease Characteristics


  • Not specified


  • See Disease Characteristics


  • No concurrent participation in any other ovarian cancer screening study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00058032

Sponsors and Collaborators
St. Bartholomew's Hospital
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Study Chair: Usha Menon, MBBS, MRCOG St. Bartholomew's Hospital
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00058032    
Other Study ID Numbers: CDR0000285690
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: September 2005
Keywords provided by National Cancer Institute (NCI):
ovarian epithelial cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type