Sponsor study identifier
observational
108
1 country
1
Study Start
June 28, 2011
Actual (reported)Primary Completion
November 3, 2017
Actual (reported)Study Completion
November 3, 2017
Actual (reported)Genes are the "blueprints" for our bodies. Some people are born with an abnormal copy ("mutation") of a gene. These people may have a higher chance of getting a disease. Different mutations in different genes cause different diseases. Some women get breast cancer because they are born with an abnormal copy of a gene called BRCA1 or BRCA2. These women also have a higher chance of getting ovary cancer. Women with breast cancer and an abnormal copy of BRCA1 or BRCA2 also have a higher chance of getting a second breast cancer in their other breast. Because of this, women who might have a mutation may have genetic testing soon after their breast cancer diagnosis to learn about their risks of getting another cancer. Genetic testing may be done right after a woman has been diagnosed with breast cancer. It may also be done later, after surgery is done to treat the cancer. The investigators do not know when it is best to do genetic testing. The investigators are doing this study to try to understand whether women prefer testing before or after surgery. The investigator also want to find out how they feel about their choice later on, when their diagnosis in more in their past.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 3, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 28, 2011
Actual (reported)June 29, 2011
Actual (reported)July 1, 2011
Actual (reported)November 3, 2017
Actual (reported)November 3, 2017
Actual (reported)To determine the relative proportions of women offered genetic testing after a breast cancer diagnosis who decide to have BRCA testing
Either before completing definitive local surgical treatment (pre-surgical testing), after definitive surgical treatment (post-surgical) Women will be evaluated for their levels of general and cancer specific distress, coping style, and stage of decision-making with respect to PM (as this is the primary clinical reason for undergoing immediate testing).
2 years
To determine the relative proportions of women who decide to undergo prophylactic mastectomy (PM)
2 years
To assess the factors associated with the decision to choose pre- or post surgical testing.
2 years
The proposed investigation is a prospective cohort study. Women with newly diagnosed breast cancer will decide whether to undergo BRCA testing either before or after completion of local surgical treatment.
If they consent to enroll, they will complete an instrument evaluating their beliefs regarding the value of genetic testing (Assessment 1). After that, they will decide whether they wish to attend an information session on genetic predisposition. If they do, after completing that information session they will complete a follow-up instrument (Assessment 2), and will then decide to either immediately donate a sample for immediate testing, or to defer the decision until after surgery. Women will be given the results of their genetic testing in the context of a standard results counseling session, after which they will continue with clinical care. They will be followed for clinical decision, especially whether or not they undergo CPM.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This is a prospective study of women who meet a subset of the NCCN criteria for genetic testing and are presenting to the Breast Surgery Clinic for treatment of a newly diagnosed breast cancer.
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
peripheral blood leucocytes and/or mouthwash-collected buccal epithelial cells)
Mark Robson, MD
Memorial Sloan Kettering Cancer Center
108 participants (actual enrollment reported by the registry).
First Submitted
June 29, 2011
First Posted
July 1, 2011
Study Start
June 28, 2011
Actual (reported)Ethnic Differences in the Impact of Breast Cancer on Employment Status, Financial Situation, and Quality of Life
Contact the study team to confirm eligibility.
Primary Completion
November 3, 2017
Actual (reported)Study Completion
November 3, 2017
Actual (reported)Last Updated
November 8, 2017
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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