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Prevention of Ovarian Cancer in Women Participating in Mammography

Fred Hutchinson Cancer Center (FHCC) logo

Fred Hutchinson Cancer Center (FHCC)

Status

Completed

Conditions

Epithelial Ovarian Cancer

Treatments

Behavioral: genetic counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT01851109
1R18DP001142-01

Details and patient eligibility

About

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.

Enrollment

458 patients

Sex

Female

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

458 participants in 2 patient groups

Control
No Intervention group
Genetic counseling
Experimental group
Description:
After randomization the participant is offered a referral to a genetic counselor.
Treatment:
Behavioral: genetic counseling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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