CA 125 and Ultrasound in Detecting Ovarian Cancer in Postmenopausal Women - Full Text View

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

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer

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
Study Completion Date:	March 2009

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

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, see Learn About Clinical Studies.

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. doi: 10.1016/S1470-2045(10)70268-0. 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 Apr;10(4):327-40. doi: 10.1016/S1470-2045(09)70026-9. Epub 2009 Mar 11.


ClinicalTrials.gov Identifier:	NCT00058032 History of Changes
Other Study ID Numbers:	CDR0000285690, UKCTOCS, EU-20249
Study First Received:	April 7, 2003
Last Updated:	December 3, 2013
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):


ovarian epithelial cancer

Additional relevant MeSH terms:


Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases, Female Genital Neoplasms, Female	Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Urogenital Neoplasms

ClinicalTrials.gov processed this record on February 27, 2015