Biomarkers for the Detection of Lymphatic Insufficiency (Biomarkers)

November 20, 2023 updated by: Stanley Rockson, Stanford University
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who receive their care within Dr. Rockson's clinic in the Stanford Center for Lymphatic and Venous Disorders may be spoken to about voluntary participation in this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort with lymphedema
Participants with a history of acquired lymphedema of at least 6 months' duration, will have phlebotomy for serum and plasma.
Procedure: phlebotomy
phlebotomy for collection of plasma and serum, ~30 cc
Other Names:
  • venipuncture
Cohort without lymphedema
Healthy volunteers; will have phlebotomy for serum and plasma.
Procedure: phlebotomy
phlebotomy for collection of plasma and serum, ~30 cc
Other Names:
  • venipuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biomarkers for the Detection of Lymphatic Vascular Insufficiency
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Stanley G Rockson, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimated)

March 2, 2015

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17690

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

to be determined

IPD Sharing Time Frame

Available one year after the last study visit and for one year duration.

IPD Sharing Access Criteria

Requestors will be required to complete a Data Access Agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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