LymphedemaLYMPHODYSNCT05629026
Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema
A study testing Micro-biopsies in people with Lymphedema, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- Micro-biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2024to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
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- 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.
- Patient under guardianship or trusteeship, persons placed under the protection of justice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Toulouse Hospital
Toulouse
Julie MALLOIZEL-DELAUNAY, MD
About this study
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.
Read the detailed description
Primary lymphedema is an inherited condition whereas secondary lymphedema develops after cancer treatments. Despite common phenotype, a molecular and histological comparison of these two pathologies has never been performed. Primary lymphedema is associated with heterozygous inactivating mutations of the gene encoding vascular endothelial growth factor C and D receptor (VEGFR-3). Primary lymphedema is rare, affecting 1 in 100,000 individuals. Secondary lymphedema is the most common cause of the disease and affects more than 200 million people worldwide.
Secondary lymphedema occurs months, sometimes years after cancer surgery suggesting that lymphedema is not only a side effect of the surgery, but involves modifications of the lymphatic architecture as well as its microenvironment, in particular adipose tissue that accumulates in the limb.
There is no cure for lymphedema because of the lack of identified therapeutic strategies able to restore collecting lymphatic draining function in the arm or in the leg. The goal will be to establish if these pathologies which possess a common denomination exhibit a similar gene expression.
- Conditions
- Lymphedema
- Being tested
- Micro-biopsies
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-biopsiesProcedure or surgery
Two micro-biopsies of limb tissue will be carried out, one on the lymphedema and one in the upper limb not affected.
| Study group | Role | What they receive |
|---|---|---|
| primary lymphoedema | Experimental | patients with primary lymphoedema Receives: Procedure: Micro-biopsies |
| secondary lymphoedema | Experimental | patients with secondary lymphoedema Receives: Procedure: Micro-biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (3)
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
Measured: Day 1
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
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start21 Feb 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- cross-sectional sample of patients with primary or secondary lymphoedema.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Malloizel-Delaunay, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629026
- Sponsor's protocol ID
- RC31/22/0128
- Acronym
- LYMPHODYS
- Status last verified
- Dec 2025
- First submitted
- 3 Oct 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema
- ClinicalTrials.gov ID
- NCT05629026
- Acronym / sponsor ID
- LYMPHODYS / RC31/22/0128
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary lymphedema is an inherited condition whereas secondary lymphedema develops after cancer treatments. Despite common phenotype, a molecular and histological comparison of these two pathologies has never been performed. Primary lymphedema is associated with heterozygous inactivating mutations of the gene encoding vascular endothelial growth factor C and D receptor (VEGFR-3). Primary lymphedema is rare, affecting 1 in 100,000 individuals. Secondary lymphedema is the most common cause of the disease and affects more than 200 million people worldwide.
Secondary lymphedema occurs months, sometimes years after cancer surgery suggesting that lymphedema is not only a side effect of the surgery, but involves modifications of the lymphatic architecture as well as its microenvironment, in particular adipose tissue that accumulates in the limb.
There is no cure for lymphedema because of the lack of identified therapeutic strategies able to restore collecting lymphatic draining function in the arm or in the leg. The goal will be to establish if these pathologies which possess a common denomination exhibit a similar gene expression.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cross-sectional sample of patients with primary or secondary lymphoedema.
| Arm | Type | Receives |
|---|---|---|
| primary lymphoedema | Experimental | Procedure: Micro-biopsiespatients with primary lymphoedema |
| secondary lymphoedema | Experimental | Procedure: Micro-biopsiespatients with secondary lymphoedema |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Patients with no recidive > 3 years after cancer surgery.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-biopsiesTwo micro-biopsies of limb tissue will be carried out, one on the lymphedema and one in the upper limb not affected. | Procedure or surgery | primary lymphoedema, secondary lymphoedema |
Primary outcome
Number of RNA transcripts between lymphoedema limb and healthy limb
Time frame: 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.
3 secondary outcomes
LYVE-1 expression in primary and secondary lymphedema by immuno-histology
Time frame: Day 1
Podoplanin expression in primary and secondary lymphedema by immuno-histology
Time frame: Day 1
Chromatography analysis of Lipids in adipose tissues from primary and secondary lymphoedema
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Malloizel-Delaunay, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-biopsies in people with Lymphedema, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie MALLOIZEL-DELAUNAY, MD (+33 (0)5 61 32 30 33, malloizel-delaunay.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of RNA transcripts between lymphoedema limb and healthy limb (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.