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Home » Northwestern Launches Gene Banking Project
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Northwestern Launches Gene Banking Project

By medwebOct 25, 2002
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October 25, 2002

Northwestern Launches Gene Banking Project

CHICAGO— The Center for Genetic Medicine at Northwestern University has launched a major gene banking project that will use information from the human genome sequence to unravel the genetic cause of many diseases and eventually help scientists develop new tests, determine which patients will respond best to a particular drug, and develop therapies to fight specific illnesses.

The project, called NUgene, is a collaboration of The Feinberg School of Medicine at Northwestern University, Northwestern Memorial Hospital (NMH), Evanston Northwestern Healthcare (ENH), and the Northwestern Medical Faculty Foundation (NMFF). NUgene is headed by Rex L. Chisholm, PhD, professor of cell and molecular biology at the Feinberg School and director of the Center for Genetic Medicine, and staffed by a team of leading Northwestern scientists and genetic counselors.

NUgene’s goal is to collect thousands of DNA samples and related health information that will be used to search out “candidate genes” believed to play a role in disease, ascertain their role in the disease process, and determine, based on an individual’s genetic information and medical history, which therapies would be most effective.

“Someday, the NUgene project may enable us to understand enough about the proteins produced by candidate genes that they can then be targeted as therapies,” Dr. Chisholm said.

Genetic studies are traditionally based on smaller populations, using pedigrees or family studies, but future genetic research will tackle disease with multiple gene and environmental factors.

Such studies will require access to thousands of DNA samples for genotyping and associated patient information from diverse populations, Dr. Chisholm said.

“These studies may dramatically improve patient care through identification of patients who will be responsive to certain therapies, providing early disease screening opportunities based on patient predisposition, and development of new diagnostic tests and therapies,” he said.

The diverse group of 2,000 participants to be recruited for the initial phase of the NUgene project will be patients of NMH, NMFF, and ENH. The study population will vary in age, sex, ethnicity, and state of health and must be at least 18 years old.

Recruitment will occur in NMFF’s General Internal Medicine Clinic and will expand to include other NMFF clinics. Genetic counselors will be available throughout the study to answer questions and educate and enroll participants.

Participation in the NUgene project requires one clinic visit during which a single blood sample will be collected. A device will be used that purifies up to 96 samples of RNA and DNA from blood in about eight hours and tracks each sample throughout the process.

Researchers will perform various genetic tests on the samples, such as whole genome scans, microsatellite analysis, SNP analysis, and DNA sequencing. The DNA obtained from each blood sample will be stored at the NUgene laboratories indefinitely or for as long as the participant is in the project.

Participants will complete a short questionnaire and will be asked to agree to allow ongoing access and review of their medical and billing records for any visits to the medical centers in the study for as long as they remain in the NUgene project.

Information derived from the participant’s medical records and questionnaire will be compared with the results of the DNA studies.

The medical information in the NUgene database will be updated two to four times each year for as long as a participant remains in the NUgene project. Participants will have the option of being contacted for further questions about their health or to be asked to take part in further research studies.

All information entered into the research database will be coded to protect the participant’s confidentiality and will not be shared with his/her physician, insurance provider, employer, or family members. Each participant and blood sample will be assigned a unique serial number that is randomly generated by a computer. This database contains the only link between the participant’s name, medical record number, and serial number.

The database, stored in a secure facility at Northwestern University with strictly limited access, will be encrypted (intentionally scrambling the letters and numbers) so that its contents are legible only to those with security clearance.

After DNA is isolated from a blood sample, it will be identified only by a unique serial number and not the participant’s name, Social Security number, or medical record number. Thus, any DNA or medical information released to other researchers will not include any personal identification.

Researchers using the NUgene bank will not be allowed direct access to the system but will receive reports that provide them only the information they need and for which they have approved access. This provides an additional level of security for the data held in the NUgene database.

Importantly, the NUgene project has been granted a Certificate of Confidentiality from the National Institutes of Health. This certificate protects all samples and participant information from legal action, such as subpoenas.

None of the information obtained from the DNA studies will be shared with participants or their physicians, but participants may gain the satisfaction of helping researchers understand the role of genes in the disease process and eventually use the results of the NUgene project to develop highly targeted genetic therapies.

For information on the NUgene study, call 312/503-4395.

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