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

Study acronym: CFAbd-Score
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study description expanded, about 25 words
    • Publications: 6 to 7
    • Eligibility criteria expanded, about 4 words
    v8
  2. Publications: details revised at 1 of 6 entriesv7
  3. Primary completion date: Dec 31, 2024 to Dec 31, 2026v6 Show 7 more changesShow less
    • Primary endpoints: 1 to 2
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    • Interventions: Questionnaire (Other) to Questionnaire Patient Reported Outcome Measure (PROM) (Diagnostic Test)
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description expanded, about 14 words
    • Study sites revised (2)
    • Publications: 4 to 6
  4. Enrollment target: 1000 to 2000
    • Primary completion date: Dec 31, 2021 to Dec 31, 2024
    • Study completion date: Dec 31, 2022 to Dec 31, 2025
    • Secondary endpoints: details revised at 1 of 3 entries
    v5
  5. Lead sponsor: University of Jena to Medizinische Hochschule Brandenburg Theodor Fontane
    • Collaborator revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Dec 31, 2020 to Dec 31, 2021v3 Show 8 more changesShow less
    • Primary endpoint revised
    • Study sites: 1 to 2
    • Study completion date: Dec 31, 2021 to Dec 31, 2022
    • Secondary endpoints expanded, about 46 words
    • Collaborators: 2 to 1
    • Publications: details revised at 1 of 4 entries
    • Study title expanded, about 6 words
    • Study description shortened, about 1 word
  2. Primary completion date: Jan 31, 2019 to Dec 31, 2020v2 Show 4 more changesShow less
    • Primary endpoint revised
    • Study completion date: Jan 31, 2020 to Dec 31, 2021
    • Publications: 2 to 4
    • Collaborators expanded, about 5 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03052283
Lead Sponsor Medizinische Hochschule Brandenburg Theodor Fontane
Collaborators: University of Jena
Conditions
(from sponsor)		 Cystic Fibrosis
Related terms Cystic Fibrosis, Diabetes Mellitus
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov