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NCT02375165 Clinical Trial

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
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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