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H · S · G PHAROS: Prospective Huntington At Risk Observational Study PHAROS has completed enrollment as of January 2004, (but remains active with those who have already enrolled) What is the PHAROS Project? PHAROS aims to define the natural history and experiences of people who are at risk of developing HD and who do not know their gene status. The HSG research sites plan to recruit about 1,000 individuals. The PHAROS project is an observational study in North America (US and Canada) of people ages 26-55 who are at risk for Huntington's Disease and have never been tested for the HD gene. During the study, subjects will be evaluated every nine (9) months (for a minimum of 3 years) using a clinical survey known as the Unified Huntington's Disease Rating Scale (UHDRS), which looks at movement, psychological and behavioral function. A blood sample will also be taken at the beginning of the study, and will be confidentially tested to determine if the participant has the gene for HD. Neither the participant nor any of the physicians or coordinators of PHAROS will ever learn the results of individual gene tests. Why is the HSG observing people at risk for Huntington's Disease? To date, little research has been done on individuals who are at risk for developing an inherited disease (such as the children of a person with HD). We hope this study will help us to answer some important questions, such as:
We hope that this study may provide some essential information for future trials of experimental drugs for HD. Who is elligible to participate in PHAROS? Individuals:
My family and/or my employer don't know I'm at risk for HD. How will my confidentiality be maintained? Confidentiality is a central concern in the PHAROS study, and we have designed the study to protect the confidentiality of research subjects to the fullest extent possible. Names will not appear on the study forms - instead, a code number will be assigned to identify research participants. A bar code (different from the subject code) will be used to identify blood samples and DNA results. As mentioned previously, DNA results will not be provided to research participants or any of the physicians or staff at the site where the study is being conducted - instead, it will be sent in a coded fashion (which does not identify individuals by name) to a central location at the University of Rochester. I'm interested in the study, but would prefer not to learn my DNA results or whether I am developing signs of HD. Is it possible to still participate? Yes. Participants will never learn their DNA results through the PHAROS study, even when the study is complete. (Participants can, of course, arrange for DNA testing at an independent laboratory outside of the study.) Participants will also not be told if they are developing signs of HD. (Again, if participants decide they do want to know this information, they will need to arrange for an evaluation outside of the scheduled PHAROS study visits.) Are there any risks to me as a participant in PHAROS? Some psychological stress may occur from participation in PHAROS (due to concern over whether you are showing signs of the illness or whether you have the gene). There are also some minor risks when blood is drawn for the blood sample. These risks are further explained in the consent form, and the research investigator or coordinator can also answer any questions. What is the benefit to me of participating in PHAROS? There is no direct health benefit from participating in PHAROS. However, participation may help to provide information useful for a better understanding of the onset of illness in healthy persons at risk for HD. How do I find out more information about participating in the PHAROS Study? As of January 2004, PHAROS has completed enrollment. However, If you are interested in learning more about this study, please contact Dawn Radtke, at 612-873-2943, or the Huntington Study Group at our toll-free number 1-800-487-7671. |
HDSA Center of Excellence at Hennepin County Medical Center