Epithelial Ovarian CancerNCT01851109
Prevention of Ovarian Cancer in Women Participating in Mammography
A study testing genetic counseling in people with Epithelial Ovarian Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- genetic counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Previous diagnosis of ovarian cancer
- Prior bilateral-salpingo oophorectomy
- Had a negative genetic test result for a known family genetic mutation
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
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
- Epithelial Ovarian Cancer
- Being tested
- genetic counseling
- Keywords
- ovarian cancer, prevention, prophylactic surgery, risk, biomarkers, screening, symptoms
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Genetic counseling | Experimental | After randomization the participant is offered a referral to a genetic counselor. Receives: Behavioral: genetic counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms
Measured: 24 months post-enrollment
Secondary outcomes (2)
Cancer related distress
Measured: change from baseline at 12 and 24 months post-enrollment
Health-related quality of life
Measured: change from baseline at 12 and 24 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startJul 2008
- Primary completionMay 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Medical Center
- Responsible party
- Sponsor
- Investigators
- Nicole Urban, ScD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851109
- Sponsor's protocol ID
- 1R18DP001142-01
- Status last verified
- Jan 2016
- First submitted
- 3 May 2013
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Ovarian Cancer in Women Participating in Mammography
- ClinicalTrials.gov ID
- NCT01851109
- Acronym / sponsor ID
- 1R18DP001142-01
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- ovarian cancer, prevention, prophylactic surgery, risk, biomarkers, screening, symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Swedish Medical Center
- Study start
- Jul 2008
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Genetic counseling | Experimental | Behavioral: genetic counselingAfter randomization the participant is offered a referral to a genetic counselor. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (3 listed)
- Previous diagnosis of ovarian cancer
- Prior bilateral-salpingo oophorectomy
- Had a negative genetic test result for a known family genetic mutation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic counselingThe 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. | Behavioural | Genetic counseling |
Primary outcome
Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms
Time frame: 24 months post-enrollment
2 secondary outcomes
Cancer related distress
Time frame: change from baseline at 12 and 24 months post-enrollment
Health-related quality of life
Time frame: change from baseline at 12 and 24 months post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Urban, ScD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genetic counseling in people with Epithelial Ovarian Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms (time frame: 24 months post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.