search
Back to results

Prevention of Ovarian Cancer in Women Participating in Mammography

Primary Purpose

Epithelial Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
genetic counseling
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epithelial Ovarian Cancer focused on measuring ovarian cancer, prevention, prophylactic surgery, risk, biomarkers, screening, symptoms

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Genetic counseling

Arm Description

After randomization the participant is offered a referral to a genetic counselor.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cancer related distress
Health-related quality of life

Full Information

First Posted
May 3, 2013
Last Updated
January 27, 2016
Sponsor
Fred Hutchinson Cancer Center
Collaborators
Swedish Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01851109
Brief Title
Prevention of Ovarian Cancer in Women Participating in Mammography
Official Title
Prevention of Ovarian Cancer in Women Participating in Mammography
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
Swedish Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
Keywords
ovarian cancer, prevention, prophylactic surgery, risk, biomarkers, screening, symptoms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
458 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Genetic counseling
Arm Type
Experimental
Arm Description
After randomization the participant is offered a referral to a genetic counselor.
Intervention Type
Behavioral
Intervention Name(s)
genetic counseling
Intervention Description
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 Outcome Measure Information:
Title
Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms
Time Frame
24 months post-enrollment
Secondary Outcome Measure Information:
Title
Cancer related distress
Time Frame
change from baseline at 12 and 24 months post-enrollment
Title
Health-related quality of life
Time Frame
change from baseline at 12 and 24 months post-enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Urban, ScD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Prevention of Ovarian Cancer in Women Participating in Mammography

We'll reach out to this number within 24 hrs