cancer genetic counseling north dakota cancer coalition cancer conference may 18, 2011
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Cancer Genetic Counseling North Dakota Cancer Coalition Cancer Conference May 18, 2011. Marie Schuetzle, MS, CGC Larissa Hansen, MS. Objectives. At the conclusion of this presentation, participants should be able to Identify individuals at risk for hereditary cancer - PowerPoint PPT PresentationTRANSCRIPT
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CANCER GENETIC COUNSELINGNORTH DAKOTA CANCER COALITION CANCER CONFERENCEMAY 18, 2011
Marie Schuetzle, MS, CGC
Larissa Hansen, MS
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Objectives
At the conclusion of this presentation, participants should be able to
Identify individuals at risk for hereditary cancer
Understand the cancer genetic counseling process
Recognize aspects of informed consent Be cognizant that medical management
will be addressed regardless of testing decisions
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Genetic Counseling
Definition Genetic counseling is the process of helping people
understand and adapt to the medical, psychological and familial implications of genetic contributions to disease.
Degree Master of Science or Master of Arts in Genetic Counseling
granted by a genetic counseling program accredited by the American Board of Genetic Counseling (ABGC)
Certification Board eligible or board certified by the American Board
of Medical Genetics (ABMG) and the American Board of Genetic Counseling (ABGC)
http://www.nsgc.org/
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National Guidelines
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Indications for Genetic Evaluation Early age of onset Multiple primary cancers in one
individual Two + family members with the same or
related cancers Rare cancer Cancer diagnosis and high risk
population
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Clinical Guidelines
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Genetic Counseling Process
Assess hereditary cancer risk No hereditary pattern Suspicious of hereditary pattern, additional
evaluation needed Hereditary cancer syndrome, testing
warranted Offer testing when appropriate Facilitate testing when desired Provide recommendations
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Risk Assessment
Personal history Family history Pathological findings National diagnostic/testing criteria Mutation risk models Genetic test results
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No Hereditary Pattern
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Possible Cancer Syndrome
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Tumor Testing Criteria
Revised Bethesda Guidelines CRC diagnosis in a patient under 50 years of age Presence of synchronous/metachronous HNPCC-
associated tumors, regardless of age CRC with MSI-H histology diagnosed in a patient
under 60 years of age CRC diagnosed in a patient with >1 first-degree
relatives with an HNPCC-associated cancer, with one of the cancers diagnosed prior to age 50
CRC diagnosed in a patient with >2 first- or second-degree relatives with HNPCC-associated cancers, regardless of age
Umar et al, 2004
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Cancer Syndrome Diagnosed
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Diagnostic Criteria
Amsterdam Criteria I Three relatives with CRC, one is a first degree relative of
the other two At least two successive generations affected At least one of the relatives with CRC was diagnosed
prior to age 50 FAP is excluded Tumors verified via pathologic examination
Amsterdam Criteria IISame as above but insert “HNPCC-associated cancer (colorectal, endometrial, small bowel, ureter, renal pelvis)” in place of CRC in first and third bullets.
Vasen et al, 1991
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Breast Cancer Example
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Breast Cancer Example
First degree relative meeting national testing criteria:
Diagnosed at any age with 2 or more close blood relatives with breast or ovarian cancer diagnosed at any age.
Family member best to test.
www.nccn.org
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Mutation Risk Models
BRCAPro Bayesian calculation taking into account first and second
degree relatives with breast and ovarian cancer, as well as those that are unaffected, tumor characteristics and oophorectomy
Myriad II Risks based on experiential data taking into account breast
and ovarian cancer in first and second degree relatives University of Pennsylvania
Risks factored from 966 families with 2 or more members with breast or ovarian cancer taking into account family history of pancreatic, prostate and male breast cancer as well
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Summary of Risk Estimates
Model Mutation Risk
BRCAPro 4.6%
Myriad 2.6%
Penn II 21% patient43% family
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Breast Cancer Risk Models
Gail Hormone history Breast cancer in first degree relatives Biopsy Race
Claus Family history of breast cancer
Tyrer-Cuzick (IBIS) Family history Hormone history AJ ancestry
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Claus EB et al. Cancer 73:643,1994
Age % Risk
59 15.7
69 22.6
79 27.4
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Genetic Counseling Process
Assess Hereditary Cancer Risk No Hereditary Pattern Suspicious of hereditary pattern, additional
evaluation needed Hereditary cancer syndrome, testing
warranted Offer testing when appropriate Facilitate testing when desired Provide Recommendations
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Informed Consent
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Basic Elements of Informed Consent for Cancer Susceptibility Testing1. Information on the specific genetic
mutation(s) or genomic variant(s) being tested, including whether the range of risk associated with the variant will impact medical care
2. Implications of a positive and negative result3. Possibility that the test will not be informative4. Options for risk estimation without genetic or
genomic testing5. Risk of passing a genetic variant to children
Modified from ASCO 2003 Statement
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Basic Elements of Informed Consent for Cancer Susceptibility Testing1. Information on the specific genetic
mutation(s) or genomic variant(s) being tested, including whether the range of risk associated with the variant will impact medical care
2. Implications of a positive and negative result3. Possibility that the test will not be informative4. Options for risk estimation without genetic or
genomic testing5. Risk of passing a genetic variant to children
Modified from ASCO 2003 Statement
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Basic Elements of Informed Consent for Cancer Susceptibility Testing1. Information on the specific genetic
mutation(s) or genomic variant(s) being tested, including whether the range of risk associated with the variant will impact medical care
2. Implications of a positive and negative result3. Possibility that the test will not be informative4. Options for risk estimation without genetic or
genomic testing5. Risk of passing a genetic variant to children
Modified from ASCO 2003 Statement
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Basic Elements of Informed Consent for Cancer Susceptibility Testing1. Information on the specific genetic
mutation(s) or genomic variant(s) being tested, including whether the range of risk associated with the variant will impact medical care
2. Implications of a positive and negative result3. Possibility that the test will not be informative4. Options for risk estimation without genetic or
genomic testing5. Risk of passing a genetic variant to children
Modified from ASCO 2003 Statement
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Basic Elements of Informed Consent for Cancer Susceptibility Testing1. Information on the specific genetic
mutation(s) or genomic variant(s) being tested, including whether the range of risk associated with the variant will impact medical care
2. Implications of a positive and negative result3. Possibility that the test will not be informative4. Options for risk estimation without genetic or
genomic testing5. Risk of passing a genetic variant to children
Modified from ASCO 2003 Statement
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Basic Elements of Informed Consent for Cancer Susceptibility Testing6. Technical accuracy of the test including, where
required by law, licensure of the testing laboratory7. Fees involved in testing and counseling and, for
DTC testing, whether the counselor is employed by the testing company
8. Psychological implications of test results (benefits and risks)
9. Risks and protections against genetic discrimination by employers or insurers
Abbreviation: DTC, direct to consumer.Modified from ASCO 2003 Statement
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Basic Elements of Informed Consent for Cancer Susceptibility Testing6. Technical accuracy of the test including, where
required by law, licensure of the testing laboratory7. Fees involved in testing and counseling and, for
DTC testing, whether the counselor is employed by the testing company
8. Psychological implications of test results (benefits and risks)
9. Risks and protections against genetic discrimination by employers or insurers
Abbreviation: DTC, direct to consumer.Modified from ASCO 2003 Statement
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Basic Elements of Informed Consent for Cancer Susceptibility Testing6. Technical accuracy of the test including, where
required by law, licensure of the testing laboratory7. Fees involved in testing and counseling and, for
DTC testing, whether the counselor is employed by the testing company
8. Psychological implications of test results (benefits and risks)
9. Risks and protections against genetic discrimination by employers or insurers
Abbreviation: DTC, direct to consumer.Modified from ASCO 2003 Statement
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Basic Elements of Informed Consent for Cancer Susceptibility Testing6. Technical accuracy of the test including, where
required by law, licensure of the testing laboratory7. Fees involved in testing and counseling and, for
DTC testing, whether the counselor is employed by the testing company
8. Psychological implications of test results (benefits and risks)
9. Risks and protections against genetic discrimination by employers or insurers
Abbreviation: DTC, direct to consumer.Modified from ASCO 2003 Statement
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Genetic Information Nondiscrimination Act (GINA)
GINA & Health Insurance Illegal for health insurers to request, require, or
use genetic information to make decisions about: Your eligibility for health insurance Your health insurance premium, contribution amounts, or
coverage terms • Illegal for your health insurer to:
Consider family history or a genetic test result a pre-existing condition
Ask or require that you have a genetic test Use any genetic information they do have to discriminate
against you, even if they did not mean to collect it GINAhelp.org
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GINA & Employment
Illegal for employers to use your genetic information in the following ways: To make decisions about hiring, firing, promotion,
pay, privileges or terms To limit, segregate, classify, or otherwise mistreat
an employee
• Illegal for an employer to request, require, or purchase the genetic information of a potential or current employee, or his or her family members.
GINAhelp.org
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Basic Elements of Informed Consent for Cancer Susceptibility Testing10. Confidentiality issues, including, for DTC
testing companies, policies related to privacy and data security
11. Possible use of DNA testing samples in future research
12. Options and limitations of medical surveillance and strategies for prevention after genetic or genomic testing
13. Importance of sharing genetic and genomic test results with at-risk relatives so that they may benefit from this information
14. Plans for follow-up after testingModified from ASCO 2003 Statement
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Basic Elements of Informed Consent for Cancer Susceptibility Testing10. Confidentiality issues, including, for DTC
testing companies, policies related to privacy and data security
11. Possible use of DNA testing samples in future research
12. Options and limitations of medical surveillance and strategies for prevention after genetic or genomic testing
13. Importance of sharing genetic and genomic test results with at-risk relatives so that they may benefit from this information
14. Plans for follow-up after testingModified from ASCO 2003 Statement
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Basic Elements of Informed Consent for Cancer Susceptibility Testing10. Confidentiality issues, including, for DTC
testing companies, policies related to privacy and data security
11. Possible use of DNA testing samples in future research
12. Options and limitations of medical surveillance and strategies for prevention after genetic or genomic testing
13. Importance of sharing genetic and genomic test results with at-risk relatives so that they may benefit from this information
14. Plans for follow-up after testingModified from ASCO 2003 Statement
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Basic Elements of Informed Consent for Cancer Susceptibility Testing10. Confidentiality issues, including, for DTC
testing companies, policies related to privacy and data security
11. Possible use of DNA testing samples in future research
12. Options and limitations of medical surveillance and strategies for prevention after genetic or genomic testing
13. Importance of sharing genetic and genomic test results with at-risk relatives so that they may benefit from this information
14. Plans for follow-up after testingModified from ASCO 2003 Statement
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Basic Elements of Informed Consent for Cancer Susceptibility Testing10. Confidentiality issues, including, for DTC
testing companies, policies related to privacy and data security
11. Possible use of DNA testing samples in future research
12. Options and limitations of medical surveillance and strategies for prevention after genetic or genomic testing
13. Importance of sharing genetic and genomic test results with at-risk relatives so that they may benefit from this information
14. Plans for follow-up after testingModified from ASCO 2003 Statement
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Post-test Counseling
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Result Disclosure and Interpretation
Negative, Positive, Variant of Uncertain Significance (VUS)
Clarify the result in terms of personal and family history True negative vs. uninformative negative
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Cancer Risk Assessment
Based on genetic test result, risk assessment models, or empiric data
Include basic risk assessments for family members when available and applicable
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Cancer Screening Recommendations
Will be addressed regardless of result Individuals with negative test result but
increased cancer risk will receive individual screening recommendations
Discuss general American Cancer Society Guidelines for the Early Detection of Cancer
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Appropriate Referrals
Long term follow up programs Clinicians/clinics for subsequent medical
management
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Resource Provision
Pre-test and post-test genetic counseling medical record documentation provided to patient
Specialized resources: Provide template or custom letter to family
to explain testing results and implications to other family members
Psychosocial support Facing Our Risk of Cancer Empowered (FORCE) Bright Pink
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Additional Testing Options
Other hereditary cancer syndromes indicated by personal or family history
Future discoveries/developments in the field of cancer genetics
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QUESTIONS?
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References
American Society for Clinical Oncology policy statement update. Genetic testing for cancer susceptibility. J Clin Oncol. 2003;21:2397–2406.
National Cancer Institute. NCI’s Community Cancer Centers Program (NCCCP). Cancer Genetic Counseling Assessment Tool. Available online at: http://ncccp.cancer.gov/.
National Comprehensive Cancer Network (2006) Clinical practice guidelines in oncology: colorectal cancer screening. www.nccn.org
Robson ME, Storm CD, Weitzel J, Wollins DS, Offit K. American Society of Clinical Oncology policy statement update: genetic and genomic testing for cancer susceptibility. J Clin Oncol. 2010;28:893-901.
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References
Schneider K. Counseling About Cancer. Strategies for Genetic Counseling, 2nd ed. New York: Wiley-Liss, 2002.
Umar A, Boland CR, Terdiman JP, et al. Revised Bethesda Guidelines for hereditary nonpolyposis colorectal cancer (Lynch syndrome) and microsatellite instability. J Natl Cancer Inst. 2004;96:261–8.
Vasen HF, Mecklin JP, Khan PM, Lynch HT. The International Collaborative Group on hereditary non-polyposis colorectal cancer (ICG-HNPCC). Dis Colon Rectum. 1991;34:424–5