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Biomarkers for the Detection of Lymphatic Insufficiency (Biomarkers)

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ClinicalTrials.gov Identifier: NCT02375165
Recruitment Status : Enrolling by invitation
First Posted : March 2, 2015
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University

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.

Condition or disease Intervention/treatment
Lymphedema Procedure: phlebotomy

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).

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biomarkers for the Detection of Lymphatic Insufficiency
Study Start Date : September 2009
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

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 Name: 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 Name: venipuncture




Primary Outcome Measures :
  1. Biomarkers for the Detection of Lymphatic Vascular Insufficiency [ Time Frame: one year ]

Biospecimen Retention:   Samples Without DNA
Serum, plasma, tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375165


Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Stanley G Rockson, MD Stanford University
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Responsible Party: Stanley Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02375165    
Other Study ID Numbers: 17690
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: to be determined
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases