NCT02983253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

3.3 years

First QC Date

December 2, 2016

Last Update Submit

December 18, 2019

Conditions

Hereditary Haemorrhagic Telangiectasia (HHT)

Outcome Measures

Primary Outcomes (1)

  • Amounts of leucocytes in patients with HHT

    November 2016 - December 2018

Secondary Outcomes (1)

  • Differences in distribution of leucocytes in patients with HHT

    November 2016 - December 2018

Other Outcomes (2)

  • Functional properties of leucocytes in patients with HHT

    November 2016 - December 2018

  • Differences in size of leucocytes in patients with HHT

    November 2016 - December 2018

Study Arms (2)

Patients with HHT

blood sample of patients with HHT

Other: blood sample

probands

blood sample of healthy controls

Other: blood sample

Interventions

blood sampleOTHER

none, only laboratory tests on blood serum

Patients with HHTprobands

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inclusion Criteria: Aged 18 or over, HHT,

You may qualify if:

  • aged 18 or over, HHT

You may not qualify if:

  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Essen

Essen, 45147, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesTelangiectasisHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Urban Geisthoff, Prof.Dr.med.

    University Hospital, Essen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Urban Geisthoff

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 6, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

December 20, 2019

Record last verified: 2019-12

Locations

DE(1)