If You're a Survivor Who Was Tested for the BRCA Mutation, This Study Needs YOU!
Contact:
http://www.armyofwomen.org/contactus
"We need breast cancer survivors in the U.S. who were tested for—and found not to have—a BRCA1 or BRCA2 genetic mutation to participate in a research study looking for new genetic risk factors for breast cancer.
Genes are units of DNA that are found in the cells inside our bodies. Genetic mutations can be inherited (passed on through families). Some women with a strong family history of breast and ovarian cancer will undergo genetic testing for inherited mutations in the BRCA1 and BRCA2 genes, known to increase a woman’s risk of developing breast and ovarian cancer. Although not all families with an extensive breast cancer history have these specific genetic mutations, they may have a different mutation which has been yet to be discovered; likewise some women who develop breast cancer at a young age don’t have the known genetic mutations. This study by a research team at Albert Einstein College of Medicine is trying to identify new genetic mutations for breast cancer.
The research team is enrolling two groups of women:
• Group 1 Family Cases – These survivors have a family history that includes at least three individual cases of breast cancer (including DCIS) and/or ovarian cancer on the same side of the family, with at least one of the cases being breast cancer. At least one other of your affected family members must be willing to participate in the study with you.
• Group 2 Very Young (Sporadic Cases) – These survivors were diagnosed with breast cancer under age 35 and do not have a family history of the disease. It does not matter how old you are now. If available, your unaffected parents will also be asked to participate in the study with you.
Please read on to learn more about what’s involved and who can participate. If this study isn’t right for you, please pass it on!
What's the study about?
The purpose of this study is to identify new genetic mutations for breast cancer. The research team will analyze blood samples from two groups of survivors: women with a strong family history of breast and/or ovarian cancer and women who had early onset breast cancer but no family history. All study participants must have been tested for— and found not to have—the BRCA1 and BRCA2 genetic mutations.
What's involved?
If you sign up for the study Genomic Analysis of Breast Cancer Risk, the research team will email you a link to an online eligibility survey. Please note that if you are signing up as a family case (Group 1), at least one other family member must be willing to participate.
If you choose to participate in the study, you (and your family member(s), if applicable) will be asked to participate in the following procedures:
• Obtain medical records, including BRCA test reports, surgical pathology reports, and documentation of cancer treatments.
• Complete a one-hour pre-test genetic counseling and consent appointment by phone. During this appointment, the genetic counselor may ask additional questions about your health and the health and genetic information of your family.
• Sign and initial the consent form.
• Complete an online questionnaire.
• Provide a blood sample, which can be drawn at your next doctor’s appointment; the research team will mail the blood collection kit to you.
• Return all of the items to the research team by FedEx, at no cost to you.
Your blood sample and all study documents will be labeled with a unique study identification number. When your study sample is processed in the laboratory, your personal identifiers will be removed.
Optional: You may choose to receive individual results from the testing performed in this study. If you choose to receive results, the research team may require another sample of blood to confirm the test result. You or your insurance company will be responsible for the cost of this testing. If you cannot afford testing, special arrangements will be considered on a case-by-case basis.
Who is conducting the study?
Harry Ostrer, MD, Albert Einstein College of Medicine, Bronx, New York.
Where?
Anywhere in the United States; all necessary participation is handled by phone, online, or through FedEx.
Who can participate?
You can sign up for the study Genomic Analysis of Breast Cancer Risk if you meet ALL of these MAIN criteria for one of the two groups:
Group 1 Family Cases:
• At least 3 family members have had breast cancer and/or ovarian cancer, including yourself, with at least one case being breast cancer.
• You have at least one affected family member who is willing to also participate in the study.
• You [and your family member(s)] have had all clinically-available BRCA genetic testing (and did not have the mutations), including screening for mutations common in certain populations (MultiSite 3 BRACAnalysis) and/or full sequencing of the BRCA1 and BRCA2 genes (Comprehensive BRACAnalysis). Your healthcare provider will be able to tell you which BRCA testing you have had.
• You are willing to provide medical records, including family history information, BRCA test results, and surgical pathology reports, to confirm eligibility.
• All participants are over the age of 18.
Group 2 Very Young (Sporadic Cases):
• You are a woman who was diagnosed with breast cancer (including DCIS) before the age of 35. It does not matter how old you are now.
• You do not have a family history of breast cancer.
• If available, your unaffected parents are willing to participate
• You have had all clinically-available BRCA genetic testing (and did not have the mutations) including screening for mutations common in certain populations (MultiSite 3 BRACAnalysis) and/or full sequencing of the BRCA1 and BRCA2 genes (Comprehensive BRACAnalysis). Your healthcare provider will be able to tell you which BRCA testing you have had.
• You are willing to provide medical records, including family history information, BRCA test results, and surgical pathology reports, to confirm eligibility.
After you respond, the research team will contact you by email to ask additional questions to be sure that the study is a good fit for you."
Contact:
http://www.armyofwomen.org/contactus
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