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Prevention of Ovarian Cancer in Women Participating in Mammography

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ClinicalTrials.gov Identifier: NCT01851109
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : January 28, 2016
Sponsor:
Collaborator:
Swedish Medical Center
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Brief Summary:
The primary purpose of this study is to evaluate the effect of systematic identification and genetic counseling referral on rates of bilateral salpingo-oophorectomy (surgery to remove both fallopian tubes and ovaries) in women having mammograms at Swedish Medical Center in Seattle, WA.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Behavioral: genetic counseling Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Ovarian Cancer in Women Participating in Mammography
Study Start Date : July 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : December 2015


Arm Intervention/treatment
No Intervention: Control
Experimental: Genetic counseling
After randomization the participant is offered a referral to a genetic counselor.
Behavioral: genetic counseling

The genetic counseling sessions are conducted by a licensed genetic counselor, certified by the American Board of Genetic Counseling and the American Board of Medical Genetics. This clinical counseling session may include, but is not limited to the following:

  1. A review of medical and family history information to determine which genetic test (BRCA, HNPCC, p53, etc.), if any, is appropriate;
  2. Discuss how the results - positive or negative - affect cancer risk
  3. Discuss how cancer risk might be managed (surveillance, prophylactic surgery, oral contraceptives, etc.);
  4. Discuss how the test is conducted and what the results might be (positive, negative, uncertain);
  5. Discuss the disadvantages of genetic testing (cost, insurance coverage, worry about insurance discrimination, uncertain results, etc.) and the psychological and emotional issues surrounding testing, etc.




Primary Outcome Measures :
  1. Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms [ Time Frame: 24 months post-enrollment ]

Secondary Outcome Measures :
  1. Cancer related distress [ Time Frame: change from baseline at 12 and 24 months post-enrollment ]
  2. Health-related quality of life [ Time Frame: change from baseline at 12 and 24 months post-enrollment ]


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prior mammogram at Swedish Medical Center
  • Willing and able to provide informed consent, primary physician information, and complete study questionnaires
  • Must meet at least ONE of the following criteria:
  • personal history of breast cancer diagnosed before age 50
  • personal history of bilateral breast cancer at any age
  • 1 or more first degree relatives with breast cancer diagnosed before age 50
  • 3 or more first or second degree relatives with breast cancer at any age
  • 2 second degree relatives with breast cancer diagnosed before age 50
  • A male relative with breast cancer at any age
  • Ashkenazi Jewish with any family history of breast or ovarian cancer
  • 1 first or second degree relative with ovarian cancer AND 1 first or second degree relative with breast cancer at any age
  • 2 first degree relatives with ovarian cancer or 2 second degree relatives with ovarian cancer or 1 first and 1 second degree relative with ovarian cancer.
  • A first degree relative with both breast and ovarian cancer (2 primaries in the same person)
  • Personal history of positive genetic test result for any of the following genes: BRCA1, BRCA2, HNPCC, or P53
  • Family history of a positive genetic test result for any of the following genes: BRCA1, BRCA2 or HNPCC

Exclusion Criteria:

  • Previous diagnosis of ovarian cancer
  • Prior bilateral-salpingo oophorectomy
  • Had a negative genetic test result for a known family genetic mutation

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 ClinicalTrials.gov identifier (NCT number): NCT01851109


Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Swedish Medical Center
Investigators
Principal Investigator: Nicole Urban, ScD Fred Hutchinson Cancer Research Center

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01851109     History of Changes
Other Study ID Numbers: 1R18DP001142-01 ( U.S. NIH Grant/Contract )
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Fred Hutchinson Cancer Research Center:
ovarian cancer
prevention
prophylactic surgery
risk
biomarkers
screening
symptoms

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