Ovarian CancerNCT01544049
Fallopian Tube Removal as a Method of Ovarian Cancer Prevention: A Descriptive Study
An observational study of Ovarian Cancer, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to better understand why women choose to have their fallopian tubes removed as a method for ovarian cancer prevention. This will be done through a paper questionnaire and phone interviews. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to 4 Sep 2018
- Phase
- Observational
- 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 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who have had their fallopian tubes removed as a method of ovarian cancer prevention.
Who may be able to join
- Female of at least 18 years of age
- Must speak English fluently
- Have had fallopian tubes removed as a method of ovarian cancer prevention
Who cannot join
- Males
- Females under the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients Salpingectomy as a Method of Ovarian Cancer Prevention: A Descriptive Study
The purpose of this study is to better understand why women choose to have their fallopian tubes removed as a method for ovarian cancer prevention. This will be done through a paper questionnaire and phone interviews. The investigators hope to gain information that will allow us to better counsel women about ovarian cancer prevention.
Read the detailed description
Women will be found eligible for this study after an eligibility questionnaire given over the phone. If one is found eligible, she will be sent a consent and paper survey to fill out and send back to the research coordinator. Once that is completed, she will be given a phone interview in order answer additional questions of interest. Lastly, the study participant will be contacted once a year over the phone to obtain follow-up information.
- Conditions
- Ovarian Cancer
- Keywords
- fallopian tube removal, salpingectomy, ovarian cancer prevention
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fallopian tube removal | Women who have had one or both fallopian tube(s) removed as method of ovarian cancer prevention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe subject experience in undergoing Salpingectomy as a means of riks reduction
Subjects will provide information on their reason for choosing salpingectomy and the process they went through in undergoing this procedure
Measured: At conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startDec 2011
- Primary completion4 Sep 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Swisher, University of Washington
- Investigators
- Elizabeth Swisher, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544049
- Sponsor's protocol ID
- STUDY00000276
- Status last verified
- Sep 2018
- First submitted
- 28 Feb 2012
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Salpingectomy as a Method of Ovarian Cancer Prevention: A Descriptive Study
- ClinicalTrials.gov ID
- NCT01544049
- Acronym / sponsor ID
- STUDY00000276
- Conditions
- Ovarian Cancer
- Keywords
- fallopian tube removal, salpingectomy, ovarian cancer prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 5 Mar 2012 (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 purpose of this study is to better understand why women choose to have their fallopian tubes removed as a method for ovarian cancer prevention. This will be done through a paper questionnaire and phone interviews. The investigators hope to gain information that will allow us to better counsel women about ovarian cancer prevention.
Detailed description
Women will be found eligible for this study after an eligibility questionnaire given over the phone. If one is found eligible, she will be sent a consent and paper survey to fill out and send back to the research coordinator. Once that is completed, she will be given a phone interview in order answer additional questions of interest. Lastly, the study participant will be contacted once a year over the phone to obtain follow-up information.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fallopian tube removal | – | –Women who have had one or both fallopian tube(s) removed as method of ovarian cancer prevention. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have had their fallopian tubes removed as a method of ovarian cancer prevention.
Key inclusion criteria (3 listed)
- Female of at least 18 years of age
- Must speak English fluently
- Have had fallopian tubes removed as a method of ovarian cancer prevention
Key exclusion criteria (2 listed)
- Males
- Females under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe subject experience in undergoing Salpingectomy as a means of riks reduction
Time frame: At conclusion of study
Subjects will provide information on their reason for choosing salpingectomy and the process they went through in undergoing this procedure
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 12 Sep 2018.
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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.
Elizabeth Swisher, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by University of Washington 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 3 inclusion and 2 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 12 Sep 2018. 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?
Describe subject experience in undergoing Salpingectomy as a means of riks reduction (time frame: At conclusion of study). 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 12 Sep 2018.