Prospective Descriptive Study of the Angiogenic T Cell Population in Subjects With Hereditary Hemorrhagic Telangiectasia (HHT) (TangRO)
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|ClinicalTrials.gov Identifier: NCT03572556|
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : November 26, 2018
Hereditary hemorrhagic telangiectasia (HHT) results from genetic deregulation of angiogenesis. It is characterized by mucocutaneous telangiectasia responsible for recurrent epistaxis affecting quality of life (anaemia, iron deficiency, social distress). More rarely, HHT is complicated by the appearance of pulmonary, hepatic or cerebral arteriovenous malformations that can lead to serious complications: cerebrovascular accidents, cerebral abscesses, high output heart failure, and massive hemoptysis (1). The intensity of symptoms increases with age but with significant individual variability, even for the same mutation in the same family. Thus, while the mutations responsible for the disease have been identified, the pathophysiology is not fully understood because these mutations do not explain the great diversity of clinical presentations. Other factors not yet identified probably play an important role. Angiogenic T cells (TANG) are a newly individualized T cell population, defined by a CD4+CXCR4+CD31+ phenotype, which plays a key role in differentiating endothelial progenitors (2).
In an earlier study, the investigators showed that patients with HHT had a decrease in CD4+ and CD8+ LT compared to a cohort of healthy subjects (3).
They hypothesize that the lymphopenia mainly involves TANG, whose quantification could make it possible to assess the individual level of angiogenesis during HHT. The evaluation of the TANG levels could thus make it possible to personalize HHT management.
|Condition or disease||Intervention/treatment|
|Hereditary Hemorrhagic Telangiectasia||Biological: Blood samples Other: Epistaxis charts|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Prospective Descriptive Study of the Angiogenic T Cell Population in Subjects With Hereditary Hemorrhagic Telangiectasia (HHT)|
|Actual Study Start Date :||June 28, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||December 2020|
Hereditary hemorrhagic telangiectasia patients
Biological: Blood samples
Other: Epistaxis charts
Three monthly epistaxis charts to be completed
Matched for age (+/- 5 ans) and sex.
Biological: Blood samples
- Average monthly duration (in minutes) of epistaxis over the 3 months following inclusion [ Time Frame: Through study completion, an average of 3 months ]
- Number/mm3 of circulating TANG (CD3+CXCR4+CD31+) at inclusion. [ Time Frame: At inclusion ]
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): NCT03572556
|Contact: Alexandre GUILHEMfirstname.lastname@example.org|
|CHU Dijon Bourgogne||Recruiting|
|Dijon, France, 21079|
|Contact: Alexandre GUILHEM 0380293432 email@example.com|