Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema
- Sponsor
- University Hospital, Toulouse
- Study ID
- NCT05629026
- Status
- Recruiting
Conditions
- Lymphedema
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Micro-biopsies — PROCEDURETwo micro-biopsies of limb tissue will be carried out, one on the lymphedema and one in the upper limb not affected.
Study Details
Lymphedema is a disorder of the lymphatic vascular system characterized by impaired lymphatic return and swelling of the extremities and accumulation of undrained interstitial fluid/lymph that results in fibrosis and adipose tissue deposition in the affected area. It can be an inherited condition (primary lymphedema) or occurs after cancer surgery and lymph node removal (secondary lymphedema). It causes a significant morbidity and is a common disabling disease affecting more than 200 million people worldwide, however there is no curative treatment for primary or secondary lymphedema.
Key Dates
- First listed
- Nov 29, 2022
- Start date
- Feb 21, 2024
- Status verified
- Dec 2025
- Primary completion
- Feb 28, 2026
- Completion
- Feb 28, 2026
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: primary lymphoedemapatients with primary lymphoedema
- Experimental: secondary lymphoedemapatients with secondary lymphoedema
Primary Outcome Measure
Number of RNA transcripts between lymphoedema limb and healthy limb [ Time Frame: Day 1 ]
Central Contacts
- Julie MALLOIZEL-DELAUNAY, MD+33 (0)5 61 32 30 33
- Charline DAGUZAN+33 (0)5 61 77 84 99
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