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NCT03052283Recruiting

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

Evaluation and Validation of a New Questionnaire to Identify and Quantify Abdominal Symptoms in Patients With Cystic Fibrosis Following FDA Guidelines: the CF Abd-Score (Primarily Named JenAbdomen-CF Score)

Source: ClinicalTrials.gov · Last updated 4 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2000 (estimated)
First submitted
9 Feb 2017
Start date
26 Jan 2017
Primary completion date
31 Dec 2026
Lead sponsor
Medizinische Hochschule Brandenburg Theodor Fontane
NCT number
NCT03052283

What you commit to

  • Study type: Observational
  • Planned participants: 2000
  • From 26 Jan 2017 to the primary completion date, 31 Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Other diseases causing abdominal symptoms (Inflammatory bowel disease (IBD), alpha 1 antitrypsin deficiency, celiac disease, food allergy, gastroenteritis, etc.)

Other

  • CF cohort:
  • Lacking ability to cooperate of patients /their families, respectively
    • Healthy controls:

Who the study is looking for

  • 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

Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medizinische Hochschule Brandenburg (MHB), University
Coordinator of this site? Confirm its status
Brandenburg an der HavelGermanyRecruiting
Klinikum Westbrandenburg
Coordinator of this site? Confirm its status
Brandenburg an der HavelGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.