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Completed

NCT Number: NCT01851109

Prevention of Ovarian Cancer in Women Participating in Mammography

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.

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic Counseling

Behavioral

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:

  • A review of medical and family history information to determine which genetic test (BRCA, HNPCC, p53, etc.), if any, is appropriate;
  • Discuss how the results - positive or negative - affect cancer risk
  • Discuss how cancer risk might be managed (surveillance, prophylactic surgery, oral contraceptives, etc.);
  • Discuss how the test is conducted and what the results might be (positive, negative, uncertain);
  • 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 outcomes

  1. Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms

    Time frame: 24 months post-enrollment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • Swedish Medical Center

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2015
First posted
May 10, 2013
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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