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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

Tracking Information
First Submitted Date June 8, 2018
First Posted Date June 28, 2018
Last Update Posted Date November 26, 2018
Actual Study Start Date June 28, 2018
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2018)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03572556 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Descriptive Study of the Angiogenic T Cell Population in Subjects With Hereditary Hemorrhagic Telangiectasia (HHT)
Official Title Prospective Descriptive Study of the Angiogenic T Cell Population in Subjects With Hereditary Hemorrhagic Telangiectasia (HHT)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population outpatient
Condition Hereditary Hemorrhagic Telangiectasia
Intervention
  • 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
Study Groups/Cohorts
  • Patients
    Hereditary hemorrhagic telangiectasia patients
    Interventions:
    • Biological: Blood samples
    • Other: Epistaxis charts
  • Controls
    Matched for age (+/- 5 ans) and sex.
    Intervention: Biological: Blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 27, 2018)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Alexandre GUILHEM 0380293432 alexandre.guilhem@chu-dijon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03572556
Other Study ID Numbers GUILHEM AMRO/AOI 2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor Centre Hospitalier Universitaire Dijon
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date June 2018