Correlation Between Haptoglobin Phenotypes and Infectious and Other Complications in Cystic Fibrosis Patients (Hp-in-CF)
Cystic Fibrosis is a genetic disease with variable severity, and a predisposition for lung infection. Usually severity is determined by the class of CF mutations, but even among patients with the same severity of mutations there is a variation of the severity of CF.
Haptoglobin has several types (phenotypes), one of them was found to be related to infectious complications.
In this study the investigators aim to find a correlation between Haptoglobin phenotypes in patients with CF and frequency of infectious complications.
To this end the investigators will collect serum from CF patients, and determine their Haptoglobin protein phenotype. The investigators will correlate Haptoglobin phenotype to retrospectively gathered data on infectious complications.
Studieoversikt
Detaljert beskrivelse
Cystic Fibrosis is a genetic disease with variable severity, and a predisposition for lung infection. The severity of the disease is determined by genetic factors (type of mutation), environmental factors (exposure to bacteria) and behavioral (adherence with therapy). Even among patients with the same severity of mutations there is a variation of the severity of CF.
Haptoglobin is a protein responsible for collecting Iron from senescent Red Blood Cells. There are two genes of Haptoglobin, numbered 1 and 2, and combinations between the two genes create three forms of proteins: 1-1, 1-2, and 2-2. The 1-1 Phenotype was found to be associated with a predisposition to infection.
In this study the investigators aim to find a correlation between Haptoglobin phenotypes in patients with CF and frequency of infectious complications.
To this end the investigators will collect serum from CF patients, and determine their Haptoglobin protein phenotype by gel- electrophoresis. The investigators will correlate Haptoglobin phenotype to retrospectively gathered data on infectious complications.
FEV1- Forced Expiratory Volume in 1 second.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Haifa, Israel, 3436209
- Carmel Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
Patients diagnosed with CF according to diagnostic criteria , between the ages of 0 and 50, who are themselves, or their parents or guardians, able to give informed consent.
Two known severe (class I , II and III) mutations
Exclusion Criteria:
none
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Cystic Fibrosis Patients
Patients with Cystic Fibrosis with two known severe (class I and class II) mutations
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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FEV1
Tidsramme: best in last 6 months
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Lung function as determined by spirometry FEV1 (% expected), normalized by age
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best in last 6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of antibiotic courses per year of follow up
Tidsramme: one year
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number of courses of antibiotics the patient received in the last year
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one year
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Number of days with antibiotics per year of follow up
Tidsramme: one year
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number of days the patient received antibiotics
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one year
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Number Hospitalizations per year
Tidsramme: one year
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events of hospitalization
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one year
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Colonization with bacteria
Tidsramme: one year
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colonization of the following bacteria: Pseudomonas aeruginosa (mucoid and non mucoid), Staph aureus (MSSA and MRSA), Hemophilus influenza, Burkholderia Cepacia complex
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one year
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Presence of CF related diabetes
Tidsramme: five years
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presence of CF related diabetes and HbA1C for diabetic patients.
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five years
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Haptoglobin phenotype
Tidsramme: one visit
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Haptoglobin phenotype in serum will be determined by gel electrophoresis
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one visit
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Michal Shteinberg, MD, Pulmonology Institute and CF Center, Carmel Medical Center
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMC-12-0093-CTIL
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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