IRB Number:

670-02

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This research study is being done to unravel the genetic predisposition to primary sclerosing cholangitis (PSC). Evidence indicates that the inherited genetic material passed from parents to their children as well as environmental factors contribute to the development of PSC. This study will help us develop novel ways to prevent, diagnose and treat PSC.

Because we look at how PSC may be passed down in families, we are also interested in studying family members of PSC patients who are not affected by PSC.

Who is Eligible to Participate in the Study?

Men and Women between the ages of 5-90 who have a history of PSC are eligible to enroll in this study. PSC patients who have undergone liver transplantation are also eligible to participate.

Family members of enrolled PSC patients between the ages of 18-90 can participate in this study.

Women of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.

Minimum Age:

5

Maximum Age:

90

What is Involved With this Study?

As a study participant you will be asked to:

1. Read and sign a written consent form if you wish to participate in this study.


2. Complete a questionnaire about your health status, diet, exercise, lifestyle/habits and medical history at the start of the study.


3. Provide information about your family history, contact information for living relatives and your permission to contact other available family members of yours, that are either affected or unaffected by PSC.


4. To provide a sample of your blood (approximately three tablespoons) for genetic testing.

Do I have to visit the Mayo Clinic in order to participate in this study?

No, you do not. If you agree to participate in this study, we will send you a mail-in blood kit and we will ask you to go to your local medical facility to obtain the blood collection. All blood tests and collection of blood specimens will be performed at NO cost to the participants.

How long will the Study run?

This is an one time participation study.

Who can I Contact for Additional Information on this Trial?

If you wish to participate in this study or if you have any questions related to this study, please contact Mr. Erik Schlicht at 507-284-4312.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• N/A

Last updated: 01/16/2009