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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

Tracking Information
First Submitted Date February 24, 2015
First Posted Date March 2, 2015
Last Update Posted Date June 29, 2021
Study Start Date September 2009
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 24, 2015)
Biomarkers for the Detection of Lymphatic Vascular Insufficiency [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers for the Detection of Lymphatic Insufficiency
Official Title Biomarkers for the Detection of Lymphatic Insufficiency
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum, plasma, tissue
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.
Condition Lymphedema
Intervention Procedure: phlebotomy
phlebotomy for collection of plasma and serum, ~30 cc
Other Name: venipuncture
Study Groups/Cohorts
  • Cohort with lymphedema
    Participants with a history of acquired lymphedema of at least 6 months' duration, will have phlebotomy for serum and plasma.
    Intervention: Procedure: phlebotomy
  • Cohort without lymphedema
    Healthy volunteers; will have phlebotomy for serum and plasma.
    Intervention: Procedure: phlebotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 28, 2021)
1000
Original Estimated Enrollment
 (submitted: February 24, 2015)
600
Estimated Study Completion Date December 2025
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT02375165
Other Study ID Numbers 17690
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: to be determined
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Responsible Party Stanley Rockson, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Stanley G Rockson, MD Stanford University
PRS Account Stanford University
Verification Date June 2021