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Correlation Between Haptoglobin Phenotypes and Infectious and Other Complications in Cystic Fibrosis Patients (Hp-in-CF)

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ClinicalTrials.gov Identifier: NCT01806025
Recruitment Status : Completed
First Posted : March 7, 2013
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Michal Steinberg, Carmel Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment
Cystic Fibrosis Other: no intervention

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 142 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Correlation Between Haptoglobin Phenotypes and Infectious and Other Complications in Cystic Fibrosis Patients
Study Start Date : April 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
Cystic Fibrosis Patients
Patients with Cystic Fibrosis with two known severe (class I and class II) mutations
Other: no intervention



Primary Outcome Measures :
  1. FEV1 [ Time Frame: best in last 6 months ]
    Lung function as determined by spirometry FEV1 (% expected), normalized by age


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Haptoglobin phenotype [ Time Frame: one visit ]
    Haptoglobin phenotype in serum will be determined by gel electrophoresis


Biospecimen Retention:   Samples Without DNA
Peripheral blood serum


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with CF
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806025


Locations
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Israel
Carmel Medical Center
Haifa, Israel, 3436209
Sponsors and Collaborators
Carmel Medical Center
Investigators
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Principal Investigator: Michal Shteinberg, MD Pulmonology Institute and CF Center, Carmel Medical Center

Publications of Results:
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Responsible Party: Michal Steinberg, Pulmonology Consultant, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01806025     History of Changes
Other Study ID Numbers: CMC-12-0093-CTIL
First Posted: March 7, 2013    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michal Steinberg, Carmel Medical Center:
Cystic Fibrosis
Haptoglobin
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases