CLINSEQ®: A Large-Scale Medical Sequencing Clinical Research Pilot Study
Study Eligibility & Enrollment
Am I eligible to join CLINSEQ®?
We are looking for people who:
- Are between the ages of 45 and 65 years
- Have NOT smoked any cigarettes in the last year
- Live in the local area, or are willing to return to the area several times over the coming years at their own expense
- Have a primary care physician or have access to a community health center
- Do not have a parent, sibling or child who is already in CLINSEQ®
We want to diversify our study group and are very interested in individuals who:
- Have a known history of heart disease (such as heart attack, bypass surgery or stent).
- Are African-American/Black, either with or without a history of heart disease.
If you or someone you know meets these criteria and is interested in joining the study, please call our research assistant at 301-443-6160. They will ask you a few questions to make sure you are eligible to join the study, and can tell you more about the project.
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What are the benefits of joining CLINSEQ®?
Possible benefits to you may include:
- Free clinical testing, such as testing for cholesterol and diabetes.
- Free CAT scan to detect coronary artery disease.
- Finding gene changes that are important to your health and/or the health of your relatives.
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What are the risks of joining CLINSEQ®?
Possible risks of the study include:
- Physical risks, such as pain or bruising as a result of the blood draw and radiation exposure during the CAT scan. These risks tend to be very rare or minor.
- Emotional risks, such as becoming upset or anxious as a result of getting testing results.
- There may be a risk that genetic information could be misused for discriminatory purposes. However, there are state and federal laws that provide some protection against this. Also, researchers on our project take measures to maintain the confidentiality of your genetic testing results.
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What happens if I join CLINSEQ®?
There are five main steps to joining our study.
- 1. Enrollment & Scheduling: Someone from our study will verify that you are eligible for the study. Then they will help you schedule your initial visit with us. We will send you a letter with information to help you prepare for your visit.
- 2. Initial CLINSEQ® Visit: You will spend 4 to 5 hours at the National Institutes of Health (NIH) in Bethesda, Md. for your initial visit. The main pieces of this visit are:
- Blood work: First, you will have about 6 to 7 tablespoons of blood taken. This blood is used for clinical and genetic testing.
- EKG, Echocardiogram and CT Scan: These are noninvasive tests that look at how your heart is working, including signs of heart disease.
- Consent: We will review the consent form and answer any questions you have about the study.
- Family & Medical History: Our genetic counselor and nurse practitioner will review and expand on these histories.
- 3. Return of Results from Initial Visit: You will receive a letter going over the results of all of your tests (including the echocardiogram, EKG, CT and blood work with the exception of the genetic testing). This letter will contain recommendations for follow-up with your doctor. Depending on the results, we may also call you and ask to speak with your doctor directly.
- 4. Ongoing Enrollment: Since it may take us years to analyze your genetic tests, most participants will only hear from us every once in awhile in the first years after their initial visit. We will send out newsletters, and we may also invite you to join spinoff studies that relate to CLINSEQ®.
- 5. Return of Genetic Results: As they become available, you will be contacted and asked whether you want to receive your genetic results. While everyone will have some results to receive, they may pertain to a wide variety of diseases, and they may or may not be medically actionable.
To contact a member of the CLINSEQ® staff, call 301-443-6160 or e-mail us at CLINSEQ@mail.nih.gov
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Last Updated: June 13, 2014