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Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema (LYMPHODYS)

Primary Purpose

Lymphedema

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Micro-biopsies
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lymphedema

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Patient under guardianship or trusteeship, persons placed under the protection of justice

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    primary lymphoedema

    secondary lymphoedema

    Arm Description

    patients with primary lymphoedema

    patients with secondary lymphoedema

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    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
    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.

    Full Information

    First Posted
    October 3, 2022
    Last Updated
    May 11, 2023
    Sponsor
    University Hospital, Toulouse
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05629026
    Brief Title
    Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema
    Acronym
    LYMPHODYS
    Official Title
    Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Toulouse

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphedema

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    cross-sectional sample of patients with primary or secondary lymphoedema.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    primary lymphoedema
    Arm Type
    Experimental
    Arm Description
    patients with primary lymphoedema
    Arm Title
    secondary lymphoedema
    Arm Type
    Experimental
    Arm Description
    patients with secondary lymphoedema
    Intervention Type
    Procedure
    Intervention Name(s)
    Micro-biopsies
    Intervention Description
    Two micro-biopsies of limb tissue will be carried out, one on the lymphedema and one in the upper limb not affected.
    Primary Outcome Measure Information:
    Title
    Number of RNA transcripts between lymphoedema limb and healthy limb
    Description
    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 1
    Secondary Outcome Measure Information:
    Title
    LYVE-1 expression in primary and secondary lymphedema by immuno-histology
    Description
    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 1
    Title
    Podoplanin expression in primary and secondary lymphedema by immuno-histology
    Description
    Podoplanin expression will be determined from immunodetection and staining performed on paraffin sections of lymphedema tissue in comparison with healthy tissue
    Time Frame
    Day 1
    Title
    Chromatography analysis of Lipids in adipose tissues from primary and secondary lymphoedema
    Description
    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 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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. Patient under guardianship or trusteeship, persons placed under the protection of justice
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julie MALLOIZEL-DELAUNAY, MD
    Phone
    +33 (0)5 61 32 30 33
    Email
    malloizel-delaunay.j@chu-toulouse.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Charline DAGUZAN
    Phone
    +33 (0)5 61 77 84 99
    Email
    daguzan.c@chu-toulouse.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julie Malloizel-Delaunay, MD
    Organizational Affiliation
    University Hospital, Toulouse
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema

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