Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 99
Updated:12/21/2018
Start Date:July 31, 2012
End Date:July 29, 2022
Contact:Christopher Dowd
Email:cdowd@pmg-research.com
Phone:828-345-5060

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A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients With Cystic Fibrosis Treated With Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors(The CF-FC Study)

This is a long-term study in cystic fibrosis patients who are participating in the Cystic
Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder
called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at
their regular clinical care visits over a 10-year period and approached if they develop
symptoms of fibrosing colonopathy for collection and use of further detailed information.

This is a prospective, observational, population-based cohort study in US cystic fibrosis
patients participating in the Cystic Fibrosis Patient Registry in order to assess the
incidence of and risk factors for fibrosing colonopathy. Cystic fibrosis (CF) patients
participating in the registry from participating sites, as well as new CF patients enrolled
in the registry at these sites over a 2-year period, will serve as the base study population
(estimated to include 24,500-25,000 cystic fibrosis patients between the first patient
encounter documented in the registry from any participating site and the 31st of July 2014).
Cystic fibrosis patients in the base study population will be followed at their regular
clinical care visits and, any patients presenting over a 10-year period with signs and
symptoms of suspected fibrosing colonopathy, based on a prospective definition, will be
approached to obtain a study-specific informed consent for collection of additional data
outside the standard registry data collection form in order to augment surveillance. Data
routinely collected via the standard CF registry will be used to determine exposure to any
specific pancreatic enzyme replacement therapy and to assess potential risk factors for the
outcome of confirmed fibrosing colonopathy. An independent adjudication panel will be
utilized to validate the diagnosis of fibrosing colonopathy based on a prospective case
definition as well as decision rules.

Inclusion Criteria:

The inclusion criteria for enrollment in the Base Study Population

- Diagnosed with cystic fibrosis,

- Enrolled in the Cystic Fibrosis Patient Registry

- Receiving medical care at a Cystic Fibrosis Foundation-accredited care center
providing data to the Cystic Fibrosis Patient Registry

Exclusion Criteria:
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