Last updated on November 2017

A research study for patients with cystic fibrosis who might have a condition called Fibrosing Colonopathy (FC).


Brief description of study

A research study for patients with cystic fibrosis who might have a condition called Fibrosing Colonopathy (FC).

Detailed Study Description

This Study will not provide or recommend any treatment or any changes to your standard medical care. If you participate, there will not be any additional doctor visits outside of your standard medical visits to the Cystic Fibrosis Care Centers. Participation in this Study will not require any additional time beyond this informed consent process. You will be followed in this Study at your regularly scheduled clinic visits from the time you agree to participate until your suspected case of FC is reviewed by the independent expert medical panel (the “participation period”). This participation period will be approximately two months.

You are being asked for permission to release medical information about your suspected case of FC for research purposes. This information will be shared with the Study researchers, governmental agencies, the companies making the pancreatic enzyme supplements and other people working on the Study. This is in addition to the information you already provide to the Cystic Fibrosis Port CF Registry.

The information collected will include all medical information associated with your suspected case of FC, including information about medicines that you have been prescribed and the results of any tests that were performed to diagnose this condition. This information will be entered into a secure database by the people working on the Study. In addition, any x-rays, other diagnostic images such as CT scans, or tissue samples that your doctor obtained to diagnose FC will be sent to another doctor assigned by the Study sponsors to get a second opinion.

All of this information will then be used by the Study team and a panel of medical experts assigned for the Study to confirm your diagnosis.

Patient Inclusion Criteria:

  • Enrolled in Port CF.
  • Diagnosis of CF.
  • Receiving medical care from a CFF-accredited care center providing data to Port CF with IRB approval for this study

Patient Exclusion Criteria:

  • Patient does not have CF or is not enrolled in Port CF

Clinical Study Identifier: TX4845

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Joan Galbraith, BS, RPh

St. Alexius Medical Center
Bismarck, ND USA
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