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Recruiting Not applicable

Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema

NCT05629026 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-02-21
Last updated
2025-12-31

Condition(s) studied

Lymphedema

Investigational drug(s) / intervention(s)

Micro-biopsies

Micro-biopsies: Two micro-biopsies of limb tissue will be carried out, one on the lymphedema and one in the upper limb not affected.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients in who developed primary lymphedema or secondary lymphedema after breast cancer treatment. 2. Male and female over the age of 18 and under 75. 3. Patient affiliated to a social security scheme in France. 4. Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study. 5. Patients with no recidive \> 3 years after cancer surgery. 6. Patients with Body Mass Index \<35. 7. Patient enrolled in a care pathway for the management of their lymphedema (medical and educational care). 8. Patients wearing a compression orthosis on the limb with lymphedema. Exclusion Criteria: 1. Patients with strong suspicion or with active bacterial or fungal infection. 2. Patient with venous insufficiency associated with lymphedema. 3. Patient with a history of deep venous thrombosis on the limb with lymphedema. 4. History of chronic inflammatory disease. 5. Active neoplasia during parallel management. 6. Patient already included in another therapeutic trial. 7. Pregnant or breastfeeding woman. 8. Metastatic cancer. 9. Bilateral breast cancer. 10. Obliterative arterial disease. 11. Multiple erysipelas. 12. Active smoking (delayed healing). 13. Medicines that may promote delayed healing (Corticosteroid therapy, immunosuppressants). 14. Medication that thins the blood (aspirin and antiplatelet agent, anti-coagulant). 15. Betadine allergy. 16. Patient under guardianship or trusteeship, persons placed under the protection of justice

Primary outcome measure(s)

  • Number of RNA transcripts between lymphoedema limb and healthy limb — Day 1
    The gene expression profile of primary and secondary lymphedema will be determined by high-throughput RNA sequencing (RNAseq) or next-generation sequencing (NGS). It is a molecular methodology that allows the rapid sequencing of thousands to millions of RNA molecules simultaneously, determining the unique and specific order of nucleic acid bases. It is a random sequencing of the whole transcriptome which is used to identify and quantify the RNA resulting from the transcription of the genome at a given time.

Trial sites (1)

FacilityCityRegionStatus
Toulouse Hospital Toulouse France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05629026 on ClinicalTrials.gov ↗ ← All trials in France