National Comprehensive Cancer Network

2000 Circle of Hope

Salt Lake City, Utah 84112

Saundra S. Buys, MD; Randall Burt, MD

801.587.9555

Saundra Buys, MD, Medical Director

801.585.3525 or toll free 800.936.6343

Randall Burt, MD, Medical Director

801.587-9555

Sancy Leachman, MD, PhD, Medical Director

801.585.0595 or toll free 866.378.4840

Douglas Adler, MD, Director

Contact the Family Cancer Assessment Clinic at 801.587.9555

Huntsman Cancer Institute publishes several newsletters that address cancer genetics topics, including inherited breast, colon, and pancreas cancer and melanoma. In addition, the physicians and genetic counselors associated with the clinics conduct in-services, grand rounds, and presentations in other professional forums.

The Huntsman Cancer Learning Center offers patients and the general public information on cancer, risk factors, prevention, treatment, and the importance of screening. The HOPE Guide presents current, accurate cancer information online at www.hopeguide.org. Huntsman Cancer Information Service is a toll-free cancer information line at 888.HCI.2100.

Clients and families may be self-referred, referred by physicians, or referred from other research projects or clinical trials. Each clinic coordinator assesses inquiries for research eligibility criteria.

Eligible participants in the research clinics receive personalized screening recommendations and information about other available risk reduction options.

Services at Huntsman Cancer Institute include the following:

· genetic counseling

· dietary education and nutritional counseling

· information about risk factors, cancer screening recommendations, and the value of early detection.

The HOPE Guide presents current, accurate cancer information online at www.hopeguide.org. Huntsman Cancer Information Service is a toll-free cancer information line at 888.424.2100.

All individuals receive counseling before genetic testing. The counselor assesses the person's expectations and perceptions regarding the risk of developing cancer, especially with respect to learning genetic status. The counselor then reviews the individual's family history and discusses prevention, early detection strategies, and general approaches to risk assessment. Genetic counseling for clients enrolled in the research clinics has two components: an educational session incorporated into the orientation session, and an individual session during which each client meets privately with the genetic counselor. Pre-test sessions are identical for research and fee-for-service clients. Research participants also complete a family history form prior to their appointment; this information is regularly reviewed and updated by research registry staff members. Some clients also complete baseline questionnaires to assess a number of psychological measures.

The consultation before genetic testing also includes a psychological assessment to gauge the client's:

· readiness to know this information

· attitudes about learning the results and the impact they may have on the individual and extended family

· available support systems, family dynamics, and family communication patterns

· personal coping abilities

This session also covers the known risks, benefits, and limitations of genetic testing.

In the fee-for-service clinics, the informed consent process focuses on the issue of DNA testing; clients sign a consent form before blood is drawn for testing.

In the research clinics, specific consent is obtained several times. Initially, clinic staff reviews information about the research process with the client and obtains consent specifically for that purpose. Each of the research clinics has unique aspects which may require additional consent processes. Clinic staff offers opportunities to understand the nuances of consent to the participants before signing any document. If the participant is a genetic testing candidate, additional discussion precedes separate consent for clinical testing.

Both clinical and research services comply with all HIPAA guidelines; in addition, the research projects maintain participant confidentiality. Clinical genetic testing conducted under the auspices of a research project generates no billing, and the clinic collects no information about insurance carriers for these participants. All genetic records are stamped with the following statement to maximize confidentiality: "Huntsman Cancer Institute is releasing this information to the health care professional with expressed authorization from the patient. Before disclosing this information to any other party or entity for any reason, please obtain direct written consent from the patient." Research clinic clients are notified that the genetic records delivered to their personal doctors bear this stamp and are advised to be alert if others ask them to sign release forms.

Genetic records are secured in a locked room separate from the main medical records. Data maintained on the computer database are also secured in a password-protected file available only to select staff members.

Myriad Genetics Laboratory performs testing for the BRCA1 and BRCA2 gene mutations. For other genes that might predispose individuals to an increased risk for developing breast, ovarian, colon, or other types of cancer, a variety of clinical commercial laboratories are used. Typically, the genetic counselor working with the family researches available laboratories before pre-test counseling and consults the medical directors to assure that appropriate testing requests are made.

The commercial laboratories used for genetic testing are CLIA-certified and CAP-approved. Their quality control policies and procedures provide surveillance and quality assurance of the laboratory tests.

Cancer risk is estimated based on genetic laboratory findings, published information about the given mutation or condition (including that from database repositories), and the patient's personal and family history and lifestyle factors.

Once results are available, the genetic counselor discusses the following in a post-test counseling session:

· Increased or decreased risk results and appropriate supportive counseling

· Ramifications of transmitting the mutation to children and future children, if the client is found to have a predisposition mutation

· Risks to other relatives and a recommendation that high-risk relatives consider enrolling in the clinic

· Support for contacting at-risk family members, including an example letter and role-playing scenarios

Additional follow-up genetic counseling is available at the client's request.

Counselors and physicians provide information about screening options specific to the patient during a post-test counseling session.

During a post-test counseling session, counselors provide both carriers and non-carriers with information about medical management choices, including the option of surgical intervention or chemoprevention, as appropriate.

Referrals are made to community support groups. In addition, if anyone meets clinical criteria for major depression or general anxiety based on a pre-counseling questionnaire, they are referred outside the high-risk clinic for further evaluation.

All clients in the High Risk Breast Cancer Clinic are enrolled in the Breast Cancer Family Registry. Huntsman Cancer Institute is one of six international sites collecting information and blood from families with a history of breast or ovarian cancer. Clients in the Familial Colon Cancer Clinic are invited into the Familial Colon Cancer Registry. The Familial Pancreas Cancer Registry enrolls and collects information from people who have had pancreas cancer and families with a history of the disease. The Melanoma Research Registry enrolls individuals with a personal or family history of melanoma, numerous moles, and/or atypical moles. All four registries serve as educational resources for individuals at risk for cancer and as a referral source for researchers. Individuals with known syndromes or strong family histories of cancer who were seen in the outpatient fee-for-service clinic are invited to enroll in an available registry as appropriate.

Genetic counselors review cases weekly with the medical directors, other counselors, and lab directors as necessary.