Biomarkers for the Detection of Lymphatic Insufficiency

Lymphedema Clinical Trial

— Biomarkers  

Official title:

Biomarkers for the Detection of Lymphatic Insufficiency

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02375165
• Other study ID #: 17690
• Status: Enrolling by invitation
• Start date: September 2009
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema

Intervention

Procedure:
• phlebotomy
phlebotomy for collection of plasma and serum, ~30 cc

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers for the Detection of Lymphatic Vascular Insufficiency		one year