Biomarkers for the Detection of Lymphatic Insufficiency

NCT02375165 | Unknown

• 1 other identifier: 17690
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• Biomarkers for the Detection of Lymphatic Vascular Insufficiency

  one year

Study Arms (2)

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

Cohort without lymphedema

Healthy volunteers; will have phlebotomy for serum and plasma.

Procedure: phlebotomy

Interventions

phlebotomy PROCEDURE

phlebotomy for collection of plasma and serum, \~30 cc

Also known as: venipuncture

Cohort with lymphedema; Cohort without lymphedema

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• For lymphedema participants:
• clinical diagnosis of lymphedema of at least 6 months' duration
• Control participants:
• no evidence of lymphedema

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, tissue

MeSH Terms

Conditions

Lymphedema

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Stanley G Rockson, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Allan and Tina Neill Professor of Lymphatic Research and Medicine

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 2, 2015
• Study Start: September 1, 2009
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Available one year after the last study visit and for one year duration.
• Access Criteria: Requestors will be required to complete a Data Access Agreement