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Immunmodulation in Patients With HHT

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ClinicalTrials.gov Identifier: NCT02983253
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Urban Geisthoff, University Hospital, Essen

Brief Summary:

Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder. Literature suggests that HHT is often associated with higher frequency of infectious diseases.

The purpose of this study is to evaluate a variety of immunologic parameters in the blood serum of HHT patients in comparison to probands.


Condition or disease Intervention/treatment
Hereditary Haemorrhagic Telangiectasia (HHT) Other: blood sample

Detailed Description:

Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and visceral arteriovenous malformations. Literature and the investigators' observation suggest that HHT is often associated with higher frequency of infectious diseases. This might be a hint for a immunocompromised situation.

The purpose of this study is to evaluate a variety of immunologic parameters in the blood serum of HHT patients in comparison to probands.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Immunmodulation in Patients With HHT
Study Start Date : June 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
Patients with HHT
blood sample of patients with HHT
Other: blood sample
none, only laboratory tests on blood serum

probands
blood sample of healthy controls
Other: blood sample
none, only laboratory tests on blood serum




Primary Outcome Measures :
  1. Amounts of leucocytes in patients with HHT [ Time Frame: November 2016 - December 2018 ]

Secondary Outcome Measures :
  1. Differences in distribution of leucocytes in patients with HHT [ Time Frame: November 2016 - December 2018 ]

Other Outcome Measures:
  1. Functional properties of leucocytes in patients with HHT [ Time Frame: November 2016 - December 2018 ]
  2. Differences in size of leucocytes in patients with HHT [ Time Frame: November 2016 - December 2018 ]

Biospecimen Retention:   Samples Without DNA
blood sample


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Inclusion Criteria: Aged 18 or over, HHT,
Criteria

Inclusion Criteria:

  • aged 18 or over, HHT

Exclusion Criteria:

  • Unable to provide informed consent

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): NCT02983253


Contacts
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Contact: Freya Droege, Dr. med. 0049 201723 ext 2481 freya.droege@uk-essen.de

Locations
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Germany
University Hospital Essen Recruiting
Essen, Germany, 45147
Contact: Freya Droege, Dr. med.    0049201723 ext 2481    freya.droege@uk-essen.de   
Sponsors and Collaborators
University Hospital, Essen
Investigators
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Principal Investigator: Urban Geisthoff, Prof.Dr.med. University Hospital, Essen

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Responsible Party: Urban Geisthoff, Prof. Dr. med. Urban Geisthoff, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT02983253     History of Changes
Other Study ID Numbers: ImmunUHEssen
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Telangiectasis
Telangiectasia, Hereditary Hemorrhagic
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities