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Biomarkers for the Detection of Lymphatic Insufficiency

NCT ID: NCT02375165

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2025-12-31

Brief Summary

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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

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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).

Conditions

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Lymphedema

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort with lymphedema

Participants with a history of acquired lymphedema of at least 6 months' duration, will have phlebotomy for serum and plasma.

phlebotomy

Intervention Type PROCEDURE

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

Cohort without lymphedema

Healthy volunteers; will have phlebotomy for serum and plasma.

phlebotomy

Intervention Type PROCEDURE

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

Interventions

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phlebotomy

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

Intervention Type PROCEDURE

Other Intervention Names

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venipuncture

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Stanley Rockson

Allan and Tina Neill Professor of Lymphatic Research and Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stanley G Rockson, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

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17690

Identifier Type: -

Identifier Source: org_study_id