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CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on April 7, 2003.   Last Updated on February 8, 2011   History of Changes
Sponsor: St. Bartholomew's Hospital
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00058032
  Purpose

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 Intervention
Ovarian Cancer
 Other: screening questionnaire administration
Procedure: annual screening

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Screening
Official Title: United Kingdom Collaborative Trial Of Ovarian Cancer Screening

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer Ultrasound
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Ovarian cancer mortality at 7 years post-randomization [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health economics at 7 years post-randomization [ Designated as safety issue: No ]
  • Quality of life at 7 years post-randomization [ Designated as safety issue: No ]
  • Feasibility of screening at 7 years post-randomization [ Designated as safety issue: No ]
  • Screen morbidity at 7 years post-randomization [ Designated as safety issue: No ]

Study Start Date: February 2003
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. 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.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058032

Sponsors and Collaborators
St. Bartholomew's Hospital
Investigators
Study Chair: Usha Menon, MBBS, MRCOG St. Bartholomew's Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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 S, Leeson S, Cruickshank D, Skates SJ, Fallowfield L, Parmar M, Campbell S, Menon U. Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort. Lancet Oncol. 2011 Jan;12(1):38-48. Epub 2010 Dec 10.
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, Campbell S, Fallowfield L, Singh N, Dawnay A, Skates SJ, Parmar M, Jacobs I. 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. 2009 Mar 10; [Epub ahead of print]

ClinicalTrials.gov Identifier: NCT00058032     History of Changes
Other Study ID Numbers: CDR0000285690, UKCTOCS, EU-20249
Study First Received: April 7, 2003
Last Updated: February 8, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on February 12, 2012



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