Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema
ConditionLymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Toulouse
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Micro-biopsies
Procedure/SurgeryTwo micro-biopsies of limb tissue will be carried out, one on the lymphedema and one in the upper limb not affected.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: primary lymphoedemaExperimental treatment 1 intervention
Group B: secondary lymphoedemaExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Day 1Secondary outcomes
1
LYVE-1 expression in primary and secondary lymphedema by immuno-histology
LYVE-1 (lymphatic vessel endothelial hyaluronan receptor-1) will be determined from immunodetection and staining performed on paraffin sections of lymphedema tissue in comparison with healthy tissue
Time frame
Day 12
Podoplanin expression in primary and secondary lymphedema by immuno-histology
Podoplanin expression will be determined from immunodetection and staining performed on paraffin sections of lymphedema tissue in comparison with healthy tissue
Time frame
Day 13
Chromatography analysis of Lipids in adipose tissues from primary and secondary lymphoedema
To describe lipid profile in adipose tissues from primary and secondary lymphoedema, in comparison to the healthy limb by chromatography analysis expressed in pg lipid/mg protein.
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov