Clinical trial · Interventional
Prevention of Ovarian Cancer in Women Participating in Mammography
NCT01851109CI-TRIAL-00020693completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| genetic counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- type
- EXPERIMENTAL
- label
- Genetic counseling
- description
- After randomization the participant is offered a referral to a genetic counselor.
- interventionNames
- Behavioral: genetic counseling
Primary outcomes (1)
- measure
- Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms
- timeFrame
- 24 months post-enrollment
Secondary outcomes (2)
- measure
- Cancer related distress
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.