Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema

NCT05629026 | Recruiting

• 1 other identifier: RC31/22/0128
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• Number of RNA transcripts between lymphoedema limb and healthy limb

  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.

  Day 1

Secondary Outcomes (3)

• LYVE-1 expression in primary and secondary lymphedema by immuno-histology

  Day 1

• Podoplanin expression in primary and secondary lymphedema by immuno-histology

  Day 1

• Chromatography analysis of Lipids in adipose tissues from primary and secondary lymphoedema

  Day 1

Study Arms (2)

primary lymphoedema

EXPERIMENTAL

patients with primary lymphoedema

Procedure: Micro-biopsies

secondary lymphoedema

EXPERIMENTAL

patients with secondary lymphoedema

Procedure: Micro-biopsies

Interventions

Micro-biopsies PROCEDURE

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

primary lymphoedema; secondary lymphoedema

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in who developed primary lymphedema or secondary lymphedema after breast cancer treatment.
• Male and female over the age of 18 and under 75.
• Patient affiliated to a social security scheme in France.
• Patients with no recidive \> 3 years after cancer surgery.
• Patients with Body Mass Index \<35.
• Patient enrolled in a care pathway for the management of their lymphedema (medical and educational care).
• Patients wearing a compression orthosis on the limb with lymphedema.

You may not qualify if:

• Patients with strong suspicion or with active bacterial or fungal infection.
• Patient with venous insufficiency associated with lymphedema.
• Patient with a history of deep venous thrombosis on the limb with lymphedema.
• History of chronic inflammatory disease.
• Active neoplasia during parallel management.
• Patient already included in another therapeutic trial.
• Pregnant or breastfeeding woman.
• Metastatic cancer.
• Bilateral breast cancer.
• Obliterative arterial disease.
• Multiple erysipelas.
• Active smoking (delayed healing).
• Medicines that may promote delayed healing (Corticosteroid therapy, immunosuppressants).
• Medication that thins the blood (aspirin and antiplatelet agent, anti-coagulant).
• Betadine allergy.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse Hospital

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Julie Malloizel-Delaunay, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie MALLOIZEL-DELAUNAY, MD

CONTACT

+33 (0)5 61 32 30 33; malloizel-delaunay.j@chu-toulouse.fr

Charline DAGUZAN

CONTACT

+33 (0)5 61 77 84 99; daguzan.c@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cross-sectional sample of patients with primary or secondary lymphoedema.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: November 29, 2022
• Study Start: February 21, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)