Breast CancerNCT01992471
Multiplex Testing for Breast Cancer Susceptibility: A Pilot Study of Subject Preferences for Information and Responses After Testing
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out what kinds of information people would like to receive from a new kind of genetic testing, and how they respond to this new kind of testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pre-test Assessment, Pre test Counseling and Blood draw
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 1 Dec 2017
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will also be eligible if they are referred to the MSKCC Clinical Genetics Service from outside providers after receiving negative full sequence BRCA1/2 results from those outside providers.
Who may be able to join
- Male or Female age 18 or older
- Personal history of breast cancer AND one of the following:
- Invasive breast cancer or DCIS diagnosed at or before age 45 Invasive breast cancer diagnosed at/before age 50 with one or more of the following:
- Limited family history (Fewer than 2 first- or second-degree female relatives in the same lineage that lived to age 45. The "limited family history" can occur on either the maternal or paternal side of the family.)
- 1 or more first-/second-degree relatives with invasive BC at/before 50
- 1 or more first-/second-degree relatives with invasive epithelial ovarian cancer (any age)
Show all 10Show fewer
- 1 or more first- or second-degree relatives with male breast cancer
- 2 or more first- or second-degree relatives with pancreas cancer
- Invasive breast cancer diagnosed at or before age 60 with at least 2 first or second-degree relatives affected with any combination of invasive breast cancer before age 50, invasive epithelial ovarian cancer at any age, male breast cancer, or pancreas cancer.
- Full sequence BRCA1 and BRCA2 testing completed with no deleterious mutation identified.
Who cannot join
- Unable to provide informed consent for testing
- Unable to complete English language questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to find out what kinds of information people would like to receive from a new kind of genetic testing, and how they respond to this new kind of testing.
- Conditions
- Breast Cancer
- Being tested
- Pre-test Assessment, Pre test Counseling, Blood draw, Post-test counseling, and post-test assessment, Follow-up assessments (6 and 12 months)
- Keywords
- BRCA1 testing, BRCA2 testing, 13-215
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-test AssessmentBehavioural
Subjects who consent to the study will complete a pre-test instrument that elucidates their baseline response to genetic testing (BRCA1/2) as measured by the Multidimensional Impact of Cancer Risk Assessment (MICRA), and their current cancer surveillance and prevention behaviors, as well asintentions to undergo surveillance and prevention in the next 6 months. The instrument will either be completed at the time of the counseling for multiplex testing, or by phone within approximately 7 days of sample donation.
Pre test CounselingBehavioural
Subjects will receive appropriate pre-test counseling that will describe the range of outcomes that may results from the multiplex testing. The subject will be asked for permission to audiotape the session for later qualitative review. An outline of the pretest counseling that will be provided. In addition to a description of the genes and syndromes being tested, subjects will receive specific education regarding the following categories and subcategories of possible results a. Definitive (informative) results, b. Variants of uncertain clinical significance (VUCS), c. Uninformative negative test results, d. d. Incidental results. Then Post-counseling selection of desired information After counseling, subjects will complete an instrument indicating which genetic test results they wish to receive. They will complete this instrument in the presence of a genetic counselor, so that the subject may ask questions in order to make the choice most consistent with their preferences.
Blood drawOther
After choosing the information they wish to receive, subjects will provide a blood sample (2 x 7 cc EDTA tubes, which will be sent to Myriad Genetics Laboratory for analysis.
Post-test counseling, and post-test assessmentBehavioural
When results are available, subjects will be asked to return for in-person communication of the results. Results will be disclosed after confirmation of information preferences in a standard genetic counseling session.
Follow-up assessments (6 and 12 months)Behavioural
At 6 and 12 months post-results transmission (+/- 4 weeks), subjects will be contacted by telephone by the study RSA to complete follow-up instruments (Assessments 3 and 4; They will complete, by phone, the MICRA. They will also describe the surveillance and prevention behaviors of the preceding 6 months, and their intentions for the next 6 months. Subjects who express a high degree of distress will be offered referral to the Counseling Service, facilitated by Dr. Hay.
| Study group | Role | What they receive |
|---|---|---|
| history of breast cancer who have undergone BRCA1/2 testing | This is a single-arm observational study. Subjects with a history of breast cancer who have undergone BRCA1/2 testing and have received uninformative findings will enroll in this study, and then receive pre-test counseling for multiplex testing. Receives: Behavioral: Pre-test Assessment; Behavioral: Pre test Counseling; Other: Blood draw; Behavioral: Post-test counseling, and post-test assessment; Behavioral: Follow-up assessments (6 and 12 months) |
What is being measured
The primary outcome is the main question the study is designed to answer.
women's preferences with respect to the type of information they would like to receive from multiplex testing
Proportions of subjects declaring a pre-test preference to receive 1) all available information, 2) all information related to breast cancer predisposition (whether or not clinical utility is established), 3) all information of established clinical utility (whether related to breast cancer risk or not), 4) only a subset of high-penetrance information (masking certain results), 5) no information.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Robson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992471
- Sponsor's protocol ID
- 13-215
- Status last verified
- Dec 2017
- First submitted
- 19 Nov 2013
- Last updated
- 5 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiplex Testing for Breast Cancer Susceptibility: A Pilot Study of Subject Preferences for Information and Responses After Testing
- ClinicalTrials.gov ID
- NCT01992471
- Acronym / sponsor ID
- 13-215
- Conditions
- Breast Cancer
- Keywords
- BRCA1 testing, BRCA2 testing, 13-215
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 25 Nov 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 purpose of this study is to find out what kinds of information people would like to receive from a new kind of genetic testing, and how they respond to this new kind of testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| history of breast cancer who have undergone BRCA1/2 testing | – | Behavioral: Pre-test Assessment, Behavioral: Pre test Counseling, Other: Blood draw, Behavioral: Post-test counseling, and post-test assessment, Behavioral: Follow-up assessments (6 and 12 months)This is a single-arm observational study. Subjects with a history of breast cancer who have undergone BRCA1/2 testing and have received uninformative findings will enroll in this study, and then receive pre-test counseling for multiplex testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will also be eligible if they are referred to the MSKCC Clinical Genetics Service from outside providers after receiving negative full sequence BRCA1/2 results from those outside providers.
Key inclusion criteria (10 listed)
- Male or Female age 18 or older
- Personal history of breast cancer AND one of the following:
- Invasive breast cancer or DCIS diagnosed at or before age 45 Invasive breast cancer diagnosed at/before age 50 with one or more of the following:
- Limited family history (Fewer than 2 first- or second-degree female relatives in the same lineage that lived to age 45. The "limited family history" can occur on either the maternal or paternal side of the family.)
- 1 or more first-/second-degree relatives with invasive BC at/before 50
Key exclusion criteria (2 listed)
- Unable to provide informed consent for testing
- Unable to complete English language questionnaire
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 |
|---|---|---|
| Pre-test AssessmentSubjects who consent to the study will complete a pre-test instrument that elucidates their baseline response to genetic testing (BRCA1/2) as measured by the Multidimensional Impact of Cancer Risk Assessment (MICRA), and their current cancer surveillance and prevention behaviors, as well asintentions to undergo surveillance and prevention in the next 6 months. The instrument will either be completed at the time of the counseling for multiplex testing, or by phone within approximately 7 days of sample donation. | Behavioural | history of breast cancer who have undergone BRCA1/2 testing |
| Pre test CounselingSubjects will receive appropriate pre-test counseling that will describe the range of outcomes that may results from the multiplex testing. The subject will be asked for permission to audiotape the session for later qualitative review. An outline of the pretest counseling that will be provided. In addition to a description of the genes and syndromes being tested, subjects will receive specific education regarding the following categories and subcategories of possible results a. Definitive (informative) results, b. Variants of uncertain clinical significance (VUCS), c. Uninformative negative test results, d. d. Incidental results. Then Post-counseling selection of desired information After counseling, subjects will complete an instrument indicating which genetic test results they wish to receive. They will complete this instrument in the presence of a genetic counselor, so that the subject may ask questions in order to make the choice most consistent with their preferences. | Behavioural | history of breast cancer who have undergone BRCA1/2 testing |
| Blood drawAfter choosing the information they wish to receive, subjects will provide a blood sample (2 x 7 cc EDTA tubes, which will be sent to Myriad Genetics Laboratory for analysis. | Other | history of breast cancer who have undergone BRCA1/2 testing |
| Post-test counseling, and post-test assessmentWhen results are available, subjects will be asked to return for in-person communication of the results. Results will be disclosed after confirmation of information preferences in a standard genetic counseling session. | Behavioural | history of breast cancer who have undergone BRCA1/2 testing |
| Follow-up assessments (6 and 12 months)At 6 and 12 months post-results transmission (+/- 4 weeks), subjects will be contacted by telephone by the study RSA to complete follow-up instruments (Assessments 3 and 4; They will complete, by phone, the MICRA. They will also describe the surveillance and prevention behaviors of the preceding 6 months, and their intentions for the next 6 months. Subjects who express a high degree of distress will be offered referral to the Counseling Service, facilitated by Dr. Hay. | Behavioural | history of breast cancer who have undergone BRCA1/2 testing |
Primary outcome
women's preferences with respect to the type of information they would like to receive from multiplex testing
Time frame: 2 years
Proportions of subjects declaring a pre-test preference to receive 1) all available information, 2) all information related to breast cancer predisposition (whether or not clinical utility is established), 3) all information of established clinical utility (whether related to breast cancer risk or not), 4) only a subset of high-penetrance information (masking certain results), 5) no information.
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 5 Dec 2017.
- Memorial Sloan-Kettering 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.
Mark Robson, MD principal investigator
Memorial Sloan Kettering 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 Breast Cancer, run by Memorial Sloan Kettering 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 10 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 5 Dec 2017. 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?
women's preferences with respect to the type of information they would like to receive from multiplex testing (time frame: 2 years). 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 5 Dec 2017.