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Completed

NCT Number: NCT01806025

Correlation Between Haptoglobin Phenotypes and Infectious and Other Complications in Cystic Fibrosis Patients

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.

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Key information

Age range

Up to 60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Carmel Medical Center

Haifa, Israel, 3436209

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Primary outcomes

  1. FEV1

    Time frame: best in last 6 months

    Lung function as determined by spirometry FEV1 (% expected), normalized by age

Secondary outcomes

  1. Number of antibiotic courses per year of follow up

    Time frame: one year

    number of courses of antibiotics the patient received in the last year

  2. Number of days with antibiotics per year of follow up

    Time frame: one year

    number of days the patient received antibiotics

  3. Number Hospitalizations per year

    Time frame: one year

    events of hospitalization

  4. Colonization with bacteria

    Time frame: one year

    colonization of the following bacteria: Pseudomonas aeruginosa (mucoid and non mucoid), Staph aureus (MSSA and MRSA), Hemophilus influenza, Burkholderia Cepacia complex

  5. Presence of CF related diabetes

    Time frame: five years

    presence of CF related diabetes and HbA1C for diabetic patients.

Other outcomes

  1. Haptoglobin phenotype

    Time frame: one visit

    Haptoglobin phenotype in serum will be determined by gel electrophoresis

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Registry information

Acronym: Hp-in-CF

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 7, 2013
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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