National Comprehensive Cancer Network

Houston, Texas

Banu Arun, MD

Karen Lu, MD

713.745.7391

Members of the MD Anderson Clinical Cancer Genetics program provide continuing education for physicians, nurses, and other health care providers on topics related to hereditary cancer identification, risk assessment, and management. Continuing education is provided through grand rounds, in-services, and presentations given throughout Texas through physician and nurse oncology education programs. Presentations on hereditary cancer are also given to cancer support groups and other community organizations.

MD Anderson operates The Learning Center, a free consumer health information center that offers high-tech computer databases and traditional information sources to help patrons learn about reducing cancer risks.

Individuals interested in genetic counseling and testing services may self-refer by calling Clinical Cancer Genetics at 713.745.7391. In addition, referrals are made via healthcare professionals within the institution and from those outside the institution. All inquiries to the MD Anderson system for genetic counseling services are reviewed by Clinical Cancer Genetics and triaged to the appropriate team.

Multidisciplinary teams with expertise in inherited breast and ovarian cancer syndromes, hereditary colorectal cancer syndromes, multiple endocrine neoplasia syndromes, and other cancer syndromes are available to provide comprehensive services. Each team obtains initial intake information and a comprehensive medical/social and family history. The family history is often obtained before the first appointment via telephone or using a family history questionnaire. Clients may be requested to bring medical records or pathology reports before the initial visit.

Comprehensive risk assessment and cancer genetic counseling services are provided by physicians and master's-level trained genetic counselors who are experts in hereditary cancer. Individuals and families are educated about the risk of developing cancer based on their personal and family history. Discussion includes a review of the benefits and risks of genetic testing when appropriate, surveillance measures, and available options for prevention. When the option of genetic testing is pursued, a thorough informed consent process is followed (see below).

The informed consent process is incorporated into the counseling session. Discussions include:

· the type of test involved

· the purpose of the test

· the specific implications of positive, negative, and inconclusive test results

· potential benefits of testing

· options and limitations of cancer surveillance and prevention following testing

· potential risks and limitations of genetic testing (confidentiality, adverse psychosocial sequelae, and discrimination issues)

· cost and availability of testing

Genetic consultation reports and genetic test results are documented in patients' MD Anderson medical record. All medical records at MD Anderson are confidential, and the institution strictly adheres to all relevant federal and state laws regarding the confidentiality of medical records.

Genetic tests for mutations in cancer susceptibility genes, which are ordered for MD Anderson patients, are generally performed by either licensed commercial labs or institutional labs with CAP/CLIA accreditation. Relevant tumor studies (microsatellite instability and immunohistochemistry) are done in-house by the Department of Pathology. Testing is occasionally done in research laboratories. Should such research laboratory testing identify a mutation, clinical confirmation through a CLIA-certified lab is recommended.

Cancer/Syndrome Gene___________

Other relevant hereditary cancer predisposition genetic tests may be ordered as appropriate and when clinically available.

MD Anderson clinical laboratories are CAP/CLIA accredited.

The multidisciplinary genetics team interprets the laboratory test results in the context of the client's personal and family history. Current literature and specific mutation databases are used in estimating the individual's risk for developing cancer.

Test results are generally disclosed in a face-to-face follow-up counseling visit. The client's risk for developing cancer and options for managing the risk are reviewed and discussed. The counseling team assists the client in coping with test results; discusses decisions and approaches to communication of test results to other health care providers, family members, and others; and helps the client develop a plan for follow-up.

The genetic counseling team offers recommendations to the client regarding appropriate screening and surveillance approaches based on his or her specific risk. Discussions include the recommended frequency for the given procedure/test and the data available to show efficacy and potential risks of the screening modality. Clients are offered follow-up, as appropriate, in the MD Anderson high-risk breast, ovarian, and/or GI screening clinics.

Medical and surgical options such as chemoprevention studies or prophylactic surgery for management of increased risk for developing cancer are reviewed at length with clients. These services are readily available within the institution and there are also mechanisms to refer clients to other NCCN institutions as appropriate.

Mechanisms for referrals for psychological and supportive counseling as well as specialized medical services are in place. For some individuals, referral to a support or peer group is beneficial.

Mutation in Childhood Cancer: Implications of a Model-a clinical research study aimed to find out why some people develop cancers and tumors, why some families have more cancers than others, and whether certain genes or regions of DNA affect a person's risk of getting cancer.

MD Anderson is embarking on multiple efforts to extend genetic counseling and genetic testing to both rural and county hospital populations.

Clinical and Predictive Genetic Testing for Multiple Endocrine Neoplasia Type 1 (MEN1) Syndrome-The goal of this research study is to confirm a diagnosis of MEN1 in individuals through genetic testing. Researchers also want to find out if there are patterns between specific changes in genes and the severity of the disease.

HNPCC and Endometrial Cancer: Chemoprevention Using the Oral Contraceptive vs. Depo-Provera-The goal of this randomized clinical research study is to study the effects of these agents on the endometrial lining in women with HNPCC after three months of using the oral contraceptive Lo-Ovral or Depo-Provera.

A Two-Arm Phase II Chemoprevention Trial in Adenomatous Polyposis Coli Patients-The goal of this clinical research study is to compare the effects of Celebrex (celexocib) alone with celecoxib plus DFMO on the growth of polyps in patients with familial adenomatous polyposis (FAP). The safety of combining the two drugs will also be studied.

A Phase 2 study of SU011248 in von Hippel-Lindau Syndrome. The goal of this clinical research study is to learn if sunitinib malate (SU011248) can help to control VHL. The safety of this drug will also be studied.

Prospective Follow-Up of Women Who are at Increased Risk for Developing Breast Cancer-A follow-up research study that monitors women who have developed breast cancer or who are at increased risk to develop breast cancer and checks for any changes in their breast-related health. The aim of this study is to identify certain factors that may play a role in breast cancer development in high-risk women.

Prospective Study of Risk-Reducing Salpingo-Oophorectomy and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer-The goal of this clinical research study is to learn more about how to care for women who are at increased risk of ovarian cancer. BRCA1 and BRCA2 are the two genes that cause most of the genetic forms of ovarian cancer, and women with changes (mutations) in these genes are more likely to get ovarian cancer than women without changed BRCA1 or BRCA2 genes.

Prospective Follow-up of Women Who are at Increased Risk for Developing Breast Cancer-A follow-up research study that monitors women who have developed breast cancer or who are at increased risk to develop breast cancer and checks for any changes in their breast-related health. The aim of this study is to identify certain factors that may play a role in breast cancer development in high-risk women.

Hereditary cancer services are provided through established MD Anderson clinical centers, and adhere to all relevant quality control procedures. Multidisciplinary case conferences are held weekly to allow for input from all members of the multidisciplinary team.

MD Anderson offers opportunities for advanced training and collaborative research including molecular genetics, genetic epidemiology, behavioral and psychosocial issues related to cancer, cytogenetics, clinical genetics, and cancer pain management. Graduate training in genetic counseling is provided at MD Anderson through its collaboration with The University of Texas Graduate School for Biomedical Sciences.