Biomarkers for the Detection of Lymphatic Insufficiency
- Conditions
- Lymphedema
- Interventions
- Procedure: phlebotomy
- Registration Number
- NCT02375165
- Lead Sponsor
- Stanford University
- Brief Summary
Acquired lymphedema is a disease that causes chronic swelling of the limb(s). It is frequently under-recognized or misdiagnosed. This study is designed to lead to the development of an accurate, noninvasive, blood test to allow testing for lymphedema. This approach is particularly useful to investigate relative responses to treatment interventions.
- Detailed Description
The validation of a sensitive and specific biomarker assay for human acquired lymphatic vascular insufficiency would represent a highly significant development for the patient community. Accurate bioassay for the presence of lymphatic vascular insufficiency should help to pave the road for future human clinical trials of experimental drugs and therapies designed to treat human lymphatic diseases. Molecular profiling will be performed in human tissues (skin) obtained by biopsy. The insights gained from these initial analyses will determine the targets for assay in human body fluids (blood).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort without lymphedema phlebotomy Healthy volunteers; will have phlebotomy for serum and plasma. Cohort with lymphedema phlebotomy Participants with a history of acquired lymphedema of at least 6 months' duration, will have phlebotomy for serum and plasma.
- Primary Outcome Measures
Name Time Method Biomarkers for the Detection of Lymphatic Vascular Insufficiency one year
- Secondary Outcome Measures
Name Time Method