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Development and Validation of a Disease Specific PROM to Assess Abdominal Involvement in Patients With CF (CFAbd-Score)

Recruitingn/aAges any - anyAllMedizinische Hochschule Brandenburg Theodor Fonta…
NCT03052283 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Development, validation and evaluation of a new multimodal questionnaire to assess and quantify the abdominal involvement in patients with the inherited life shortening multi-organ disease Cystic fibrosis. In the stepwhise development of the patient reported outcome measures (PROM) repeadedly, CF-patients, their families as well as professionals working in different fields of CF-care will be included.

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📋 Eligibility rules (as published)
Inclusion Criteria: CF cohort: Diagnosis of CF determined by * a sweat chloride of \>60 mEq/L and/or * detection of 2 disease causing CFTR mutations with evidence of organ involvement. Healthy controls: * Age-matched Exclusion Criteria: CF cohort: * Lacking ability to cooperate of patients /their families, respectively Healthy controls: * Other diseases causing abdominal symptoms (Inflammatory bowel disease (IBD), alpha 1 antitrypsin deficiency, celiac disease, food allergy, gastroenteritis, etc.)
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What it tests

  • Questionnaire Patient Reported Outcome Measure (PROM)
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Where

2 sites
Klinikum Westbrandenburg
Brandenburg an der Havel, Germany
Medizinische Hochschule Brandenburg (MHB), University
Brandenburg an der Havel, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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