Biomarkers for the Detection of Lymphatic Insufficiency

Stanford University

Status: Invitation-only

Conditions: Lymphedema

Treatments: Procedure: phlebotomy

Study type: Observational

Funder types: Other

Identifiers

NCT02375165

17690

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,000 participants in 2 patient groups

Cohort with lymphedema

Description:

Participants with a history of acquired lymphedema of at least 6 months' duration, will have phlebotomy for serum and plasma.

Treatment:

Procedure: phlebotomy

Cohort without lymphedema

Description:

Healthy volunteers; will have phlebotomy for serum and plasma.

Treatment:

Procedure: phlebotomy