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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Patients
Hereditary hemorrhagic telangiectasia patients
Biological: Blood samples
  • 5 mL dry tube to separate serum
  • Two 6 mL EDTA tubes for plasma separation
  • Eight 6 mL heparinized tubes for flow cytometry (quantification of TANG such as CD3+CD31+CXCR4+ and CEC) and quantification of angiogenesis markers.

Other: Epistaxis charts
Three monthly epistaxis charts to be completed

Controls
Matched for age (+/- 5 ans) and sex.
Biological: Blood samples
  • 5 mL dry tube to separate serum
  • Two 6 mL EDTA tubes for plasma separation
  • Eight 6 mL heparinized tubes for flow cytometry (quantification of TANG such as CD3+CD31+CXCR4+ and CEC) and quantification of angiogenesis markers.




Primary Outcome Measures :
  1. Average monthly duration (in minutes) of epistaxis over the 3 months following inclusion [ Time Frame: Through study completion, an average of 3 months ]
  2. Number/mm3 of circulating TANG (CD3+CXCR4+CD31+) at inclusion. [ Time Frame: At inclusion ]


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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
outpatient
Criteria

Inclusion Criteria:

  • Person who has given consent
  • Adult
  • Person capable of understanding spoken and written French

"Patient" group:

  • Certain HHT (3 or 4 Curacao criteria - Appendix 2):
  • Recurring epistaxis
  • Telangiectasia of the skin or mouth
  • Family hereditary context
  • Arteriovenous visceral malformations
  • Causal mutation identified
  • Person capable of completing monthly epistaxis charts

"Control" group :

- Control subjects will be matched to patients for age (+/- 5 years) and sex.

Exclusion Criteria:

  • Person not affiliated to a national health insurance scheme
  • Pregnant or breastfeeding woman
  • Protected adult
  • Hemoglobin levels less than 9 g/dl in the last 15 days
  • Progressive or recent infectious disease, autoimmune disease or cancer (less than 6 months)
  • Immunosuppressive treatment in progress or recent (less than 6 months), including systemic steroid therapy. The use of inhaled or topical steroids is not an exclusion criterion.
  • Treatment in progress or stopped less than 6 months ago or to be introduced within the next 3 months of the following medications:

    • bevacizumab
    • tranexamic acid
    • dipeptidyl peptidase 4 inhibitors (diabetic patient)
    • beta-blockers (hypertensive patient)

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): NCT03572556


Contacts
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Contact: Alexandre GUILHEM 0380293432 alexandre.guilhem@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne Recruiting
Dijon, France, 21079
Contact: Alexandre GUILHEM    0380293432    alexandre.guilhem@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03572556     History of Changes
Other Study ID Numbers: GUILHEM AMRO/AOI 2017
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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