Prospective Descriptive Study of the Angiogenic T Cell Population in Subjects With Hereditary Hemorrhagic Telangiectasia (HHT)
Keywords
Abstract
Dates
| Last Verified: | 10/31/2019 |
| First Submitted: | 06/07/2018 |
| Estimated Enrollment Submitted: | 06/26/2018 |
| First Posted: | 06/27/2018 |
| Last Update Submitted: | 02/16/2020 |
| Last Update Posted: | 02/17/2020 |
| Actual Study Start Date: | 06/27/2018 |
| Estimated Primary Completion Date: | 11/30/2020 |
| Estimated Study Completion Date: | 02/28/2021 |
Condition or disease
Intervention/treatment
Biological: Blood samples
Other: Patients
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Patients Hereditary hemorrhagic telangiectasia patients | Other: Patients Three monthly epistaxis charts to be completed |
| Controls Matched for age (+/- 5 ans) and sex. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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 (+/- 6 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) |
Outcome
Primary Outcome Measures
1. Average monthly duration (in minutes) of epistaxis over the 3 months following inclusion [Through study completion, an average of 3 months]
2. Number/mm3 of circulating TANG (CD3+CXCR4+CD31+) at inclusion. [At inclusion]
