Related Websites

Description of Clinics/Registries

1. High Risk Breast Cancer Clinic (HRBCC) and Registry
2. Familial Colon Cancer Clinic (FCCC) and Registry
3. Familial Melanoma Research Clinic (FMRC)

Research resources available to investigators

1. All clinics
2. HRBCC and Registry
3. FCCC and Registry
4. FMRC

High-Risk Cancer Clinics staff/other useful personnel

Application information

1. High-Risk Breast Cancer Clinic (HRBCC) and Registry
   Medical Director: Saundra Buys, M.D.

The HRBCC and Registry enroll individuals (affected and unaffected, male and female) from pedigrees with a strong family history of breast and/or ovarian cancer. The HRBCC was established in 1994, the Registry in 1995, to facilitate research into the genetics of breast and/or ovarian cancer.

The HRBCC/Registry have enrolled 750 participants as of 2/1/2001. Participants receive genetic and dietary education and meet with a physician for breast evaluation and to receive individual screening recommendations. Genetic counselors are available to provide information and counseling around genetic testing.

Participants provide epidemiologic, nutritional and family history data, and biologic specimens to the clinic/registry for research use. Subjects have also agreed to be contacted about possible participation in other research studies.

2. Familial Colon Cancer Clinic (FCCC) and Registry
   Medical Director: Randall Burt, M.D.

   The FCCC and Registry enroll individuals (affected and unaffected, male and female) from families with a known colon cancer or polyp syndrome (including FAP, AAPC, and HNPCC), a strong family history of colon cancer, or a diagnosis of colon cancer at a young age (i.e., <50). The FCCC was established in 1996, and the Registry in 1998, to facilitate familial colon cancer research.

   The FCCC/Registry have enrolled 655 participants as of 2/1/2001. Participants provide epidemiologic, nutritional and family history data, and biologic specimens to the clinic/registry for research use. Subjects have also agreed to be contacted about possible participation in other research studies.

3. Familial Melanoma Research Clinic (FMRC)
   Medical Director: Sancy Leachman, M.D.

The FMRC began development in 2000 with the aim to better understand links between genes, environment and melanoma by collecting blood samples, tissue specimens and questionnaire data from high risk family members and spouse controls. Total-body skin examination, biopsy, and mole-mapping enable the collection of additional critical research specimens and data. Participants receive free cancer genetics education and training in self skin examination. FMRC clinics began in July of 2001 with recruitment of high-risk melanoma families who participated in the p16 gene discovery study at the University of Utah in the 1980's and will expand to include others with a strong familial melanoma history. Subjects are consented for contact about possible participation in other research studies.

Staff members (see staff list for contact information) are available to advise and assist investigators as they develop their research project using HRCC resources. In addition, an HCI research coordinator will be assigned to a project once it is approved. This research coordinator will advise the investigator about HRCC policies and procedures, and facilitate study efforts.

If it is necessary for the approved project to have subject participation, the HRCC research coordinator will first contact the subjects to obtain consent for contact by the investigator.

Clinic Specific Resources (Note: not all resources are available for all subjects.):

High-Risk Breast Cancer Clinic (HRBCC) and Registry:

• Specimens

DNA, plasma, lymphoblast cell lines, breast and ovarian epithelial cell lines, tissue slides, fresh-frozen tissue

• Electronic data

Family histories (pedigrees), demographic information, medical history including medication history, habits and exposures, diet and exercise history, reproductive history, occupational history

Mammogram findings, CA125 and PSA assays, physical breast examination findings

RCA1 and BRCA2 status

• Paper records (without names)

General medical records, pathology reports, clinical test results (BRCA1, BRCA2, CA125, PSA, mammograms)

Familial Colon Cancer Clinic (FCCC) and Registry

• Specimens

DNA, tissue slides, fresh-frozen tissue

• Electronic data

Family histories (pedigrees), demographic information, medical history including medication history, habits and exposures, diet and exercise history, reproductive history, occupational history

DNA (genetic) status

• Paper records (without names)

Medical records relating to colon screening and surgeries, pathology reports, clinical test results (colonoscopy)

Familial Melanoma Research Clinic (FMRC)

• Specimens

Blood: DNA, plasma, transformed lymphocytes
Skin: DNA; RNA; protein; cultured cells; paraffin blocks/slides; fresh frozen tissue

• Electronic Data

Family histories (pedigrees), demographic information, medical history including melanoma treatment information, sunburn history, recreational and occupational sun exposure history, smoking and diet history

Total body skin examination findings (moles as well as pigmented lesions)

Biopsy findings: normal skin, nevi, cultured melanocytes

Mole Mapping of benign and atypical moles, and any suspected melanomas

Raman and Reflectance spectroscopy data

p16 status; other genetic status if known

• Paper Records (without names)

Biopsy/pathology reports and melanoma treatment records; total body skin examination clinical data sheets (body maps)

1. IRB review

All projects using HRCC resources must have IRB review and approval. You may submit your request to HCI simultaneously with submission to the IRB, but no access to HRCC resources will be provided until a copy of your IRB approval is on file in the HRCC Administration office.

2. Clinical Cancer Investigations Committee (CCIC) review

Because Huntsman Cancer Institute is a NIH designated Cancer Center, it is required there be a separate mechanism to review study design for cancer-related protocols. For cancer studies, IRB approval is always contingent on approval by the CCIC. Please contact Amber Lamph (585-0601) with questions.

3. Expedited review

A project is eligible for expedited review if there is to be no subject contact by the researcher, no drug administration, and the data requested are anonymous. If you feel your project is eligible for expedited review, please provide the HRCC Manager with a summary of the project and the need for HRCC resources. If the Manager confirms eligibility for expedited review, you will need to provide a copy of your IRB application and approval prior to access to HCI resources.

4. Full review

If your project does not meet the criteria for expedited review, we ask that you use the attached application format, being certain to complete all sections. (Incomplete information may delay review of your proposal.) Please send the signed, completed application to the High-Risk Cancer Clinics Manager Office, 4123 HCI. We will also need a copy of your signed IRB approval. No HCI resources will be released to you until IRB approval is on file with your application to the HRCC Manager.

Review of requests to use HRCC resources is provided by the Resource for Genetic and Epidemiologic Research (RGE) Review Committee. If you have questions about the review process, please contact the Director of RGE.

5. Amendments

All project amendments must be submitted in writing to the HRCC Administrative Office. The HRCC Manager and the RGE Director will review amendment requests that do not change the scope of the project or the resources requested. Other amendments will be reviewed by the RGE Review Committee.