Ovarian CancerNCT00486707
Ovarian Cancer Patient Questionnaire on Genetic Testing
An observational study of Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The objective of this study is to evaluate the willingness of patients with ovarian cancer to undergo genetic testing, given the cost, their understanding and acceptance of genetic testing and the possibility of targeted therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Oct 2008
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study participants with a diagnosis of ovarian cancer.
Who may be able to join
- Patients must have the diagnosis of ovarian cancer.
- Patients must be at least 18 years of age at the time of enrollment.
- Patients must be able to read and write in the English language.
Who cannot join
- Patients that are unable to speak or write in the English language. Currently, the investigators' resources in genetic counseling are limited. In the future, they plan to expand the questionnaire and study to include additional languages.
- Patients having previously undergone BRCA genetic testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Questionnaire for Ovarian Cancer Patients Regarding Acceptance and Willingness to Undergo Genetic Testing
The objective of this study is to evaluate the willingness of patients with ovarian cancer to undergo genetic testing, given the cost, their understanding and acceptance of genetic testing and the possibility of targeted therapy.
Read the detailed description
All eligible patients being seen in the Gynecology Center at the M.D. Anderson Cancer Center and at Gynecologic Oncology of Houston for follow-up or a new diagnosis of ovarian cancer will be asked to participate in this study by completing a questionnaire.
This study will end when 400 completed questionnaires have been collected. We estimate that 40-60 ovarian cancer patients are seen in the Gynecology Center at the M.D. Anderson Cancer Center each week and that 20- 40 ovarian cancer patients are seen at Gynecologic Oncology of Houston each week. The completion of 400 questionnaires will provide adequate data to address our question in an expeditious time frame. The initial phase of this study is exploratory and does not involve a comparison group.
- Conditions
- Ovarian Cancer
- Being tested
- Questionnaire
- Keywords
- Ovarian Cancer, Questionnaire, Genetic Testing, Survey
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
A questionnaire will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ovarian cancer | Not described Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' Response to Survey Questions (Yes/No)
Measured: 15-20 minutes to complete survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen H. Lu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486707
- Sponsor's protocol ID
- 2006-0996
- Status last verified
- Jul 2012
- First submitted
- 13 Jun 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lacour RA, Daniels MS, Westin SN, Meyer LA, Burke CC, Burns KA, Kurian S, Webb NF, Pustilnik TB, Lu KH. What women with ovarian cancer think and know about genetic testing. Gynecol Oncol. 2008 Oct;111(1):132-6. doi: 10.1016/j.ygyno.2008.06.016. Epub 2008 Aug 6.
PubMed 18684498
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire for Ovarian Cancer Patients Regarding Acceptance and Willingness to Undergo Genetic Testing
- ClinicalTrials.gov ID
- NCT00486707
- Acronym / sponsor ID
- 2006-0996
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Questionnaire, Genetic Testing, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 15 Jun 2007 (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 objective of this study is to evaluate the willingness of patients with ovarian cancer to undergo genetic testing, given the cost, their understanding and acceptance of genetic testing and the possibility of targeted therapy.
Detailed description
All eligible patients being seen in the Gynecology Center at the M.D. Anderson Cancer Center and at Gynecologic Oncology of Houston for follow-up or a new diagnosis of ovarian cancer will be asked to participate in this study by completing a questionnaire.
This study will end when 400 completed questionnaires have been collected. We estimate that 40-60 ovarian cancer patients are seen in the Gynecology Center at the M.D. Anderson Cancer Center each week and that 20- 40 ovarian cancer patients are seen at Gynecologic Oncology of Houston each week. The completion of 400 questionnaires will provide adequate data to address our question in an expeditious time frame. The initial phase of this study is exploratory and does not involve a comparison group.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ovarian cancer | – | Behavioral: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants with a diagnosis of ovarian cancer.
Key inclusion criteria (3 listed)
- Patients must have the diagnosis of ovarian cancer.
- Patients must be at least 18 years of age at the time of enrollment.
- Patients must be able to read and write in the English language.
Key exclusion criteria (2 listed)
- Patients that are unable to speak or write in the English language. Currently, the investigators' resources in genetic counseling are limited. In the future, they plan to expand the questionnaire and study to include additional languages.
- Patients having previously undergone BRCA genetic testing.
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 |
|---|---|---|
| QuestionnaireAlso: SurveyA questionnaire will be completed. | Behavioural | Patients with ovarian cancer |
Primary outcome
Participants' Response to Survey Questions (Yes/No)
Time frame: 15-20 minutes to complete survey
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 1 Aug 2012.
- Background: PubMed 18684498Lacour RA, Daniels MS, Westin SN, Meyer LA, Burke CC, Burns KA, Kurian S, Webb NF, Pustilnik TB, Lu KH. What women with ovarian cancer think and know about genetic testing. Gynecol Oncol. 2008 Oct;111(1):132-6. doi: 10.1016/j.ygyno.2008.06.016. Epub 2008 Aug 6.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Karen H. Lu, MD principal investigator
M.D. Anderson Cancer Center
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 M.D. Anderson 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 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 1 Aug 2012. 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?
Participants' Response to Survey Questions (Yes/No) (time frame: 15-20 minutes to complete survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00486707, which also lists 1 linked publication.
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 1 Aug 2012.