1. Do I qualify for this study?
  2. How much time will it take to do the study?
  3. What will happen if I take part in the study?
  4. What are the possible benefits?
  5. What are the possible risks?
  6. Do I have to change my medication?
  7. How do I get more information?

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  1. Do I qualify for this study?
    Lung Disease
    Volunteers, age 8 or older, with a CF genotype of DF508/DF508 or other known CFTR genotype allele may qualify for this study. We are particularly interested in those volunteers greater than 32 years old. Please contact us with the following information to see if you qualify for the study:
  2. • Your most recent Pulmonary Function Test (spirometry) results (within the past year).
    • Your height and weight. 
    • Your date of birth
    • Your CF Center and/or Physician

    Liver Disease
    Volunteers with CF, regardless of genotype and age, who have “severe” liver disease with portal hypertension (big spleen, i.e. “splenomegaly” and/or presence of enlarged vessels in the esophagus, i.e. esophageal varices) may be eligible to participate.  This would include any person who has been evaluated for a liver transplant, or has already received a liver transplant. Please contact us with the following information to see if you qualify for the study:
    •    Date of the first documentation of a big spleen (splenomegaly) or
    •    Date of the first documentation of enlarged vessels in the esophagus which may or may not be associated with bleeding (esophageal varices) or
    •    Date of liver transplant or liver transplant evaluation
    •    Your date of birth
    •    Your CF Center and/or Physician


  3. How much time will it take to do the study?
    After reading an information sheet about the study, we will ask that you speak with us and give consent to have your blood drawn and for us to obtain some information about the clinical course of your disease.  Your time for this study is a one-time visit to your physician for the blood draw.  You will then return, via prepaid Fed Ex, the blood kit back to us.

  4. What will happen if I take part in the study?
    Approximately 35 mls (2 tablespoons) of blood will be collected by inserting a sterile needle into a surface vein of the arm.  Your name will be removed from the specimens and labeled with a code number at the University of North Carolina at Chapel Hill (UNC-CH).  DNA will be extracted from the blood and the DNA will be analyzed to evaluate the absence or presence of genetic mutations in non-CF genes that may affect the clinical condition of lung or liver disease.  The clinical course of your disease will be determined by review of your medical records.  Your name and medical number will not be included in the database.

  5. What are the possible benefits?
    There is no direct immediate benefit to patients participating in this study.  However, the information obtained from testing of these blood samples may lead to a better understanding of cystic fibrosis, and may lead to improved therapy for Cystic Fibrosis.

  6. What are the possible risks?
    The major risk of this type of study relates to the newly evolving area of acquiring clinical information and DNA for genetic studies.  All data will be entered into a coded database.  The DNA data will be kept in a separate, coded database, both of which are protected under standard clinical research guidelines.  No publication, visual or oral presentation of the results of this study will include any material that will permit identification of your participation in this study. The collection of blood carries the minor risks of pain and local bleeding from the venipuncture. 

  7. Do I have to change my medication?
    This is a clinical study, but there are no medications involved in this study.  You can continue with your present medical course and visit your physician, as usual.  There are no special visits or tests, other then a single blood draw, required for this study.

  8. How do I get more information?
    Please click on the link below to request additional information about the Genetic Modifier Study for Cystic Fibrosis Lung and Liver Disease.

  9. Email:  cfmod@med.unc.edu
    Phone: 919-966-3578

    The Cystic Fibrosis Foundation is funding the collection of data and specimens for this study.



 

 

This site was developed at UNC Chapel Hill in conjunction with the UNC-CH School of Medicine and the Cystic Fibrosis Foundation.
Copyright © 2006 UNC Chapel Hill Pulmonary Research and Treatment Center, All Rights Reserved.
Updated Feb 6, 2006