Offered by: Nemours Children's
Location: Jacksonville, Fla.
A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosin
The purpose of this study is to determine the number of patients affected by Fibrosing Colonopathy (FC) and to learn more about what might cause it, including use of pancreatic enzyme supplements.
Participants would be eligible to participate in this study if he or she has Cystic Fibrosis (CF), is participating in the Cystic Fibrosis Foundation’s Patient Registry (i.e., Port CF) and has symptoms that may be the result of FC.
This study will not provide or recommend any treatment or any changes to your child’s standard medical care. If your child participates, there will not be any additional doctor visits outside of their standard medical visits to the Cystic Fibrosis Care Centers.
You are being asked for permission to release medical information about your child’s 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 that is already collected in the Cystic Fibrosis Port CF Registry.
The information collected will include all medical information associated with your child’s suspected case of FC, including information about medicines that they 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 child’s doctors 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 child’s diagnosis.
You are also being asked to release medical information about any serious undesirable symptoms your child may experience during the participation period. The information collected will include all medical information associated with the symptoms, including information about medications and therapies that your child has been prescribed to treat these symptoms. This information will be provided to medical experts outside of your normal clinic to independently assess your child’s suspected diagnosis.
As part of this Research Study, your child’s CFF Registry identification (ID) number will be collected to provide a needed link with their data in the registry database.
If your child or their partner becomes pregnant during the participation period, your child will be asked questions about the pregnancy and the health of the baby.
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