Lymphedema
Conditions
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).
Interventions
PROCEDUREphlebotomy
phlebotomy for collection of plasma and serum, \ 30 cc
Sponsors
Stanford University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
For lymphedema participants: * clinical diagnosis of lymphedema of at least 6 months' duration Control participants: * no evidence of lymphedema
Exclusion criteria
For lymphedema participants: * active cancer * infection * bleeding tendency * active coronary artery disease * congestive heart failure * history of stroke or transient ischemic attack (TIA) * uncontrolled hypertension * renal insufficiency (serum creatinine \> 1.1) * active inflammatory or autoimmune disease (other than lymphedema) For control participants: * lymph node dissection * radiation therapy * active inflammatory disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biomarkers for the Detection of Lymphatic Vascular Insufficiency | one year |
Outcome results
None listed