LymphedemaBiomarkersNCT02375165
Biomarkers for the Detection of Lymphatic Insufficiency
An observational study of Lymphedema, run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lymphedema
- What is being tested?
- phlebotomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- For lymphedema participants:
- clinical diagnosis of lymphedema of at least 6 months' duration
- Control participants:
- no evidence of lymphedema
Who cannot join
- For lymphedema participants:
- active cancer
- infection
- bleeding tendency
- active coronary artery disease
- congestive heart failure
Show all 14Show fewer
- 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
About this study
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.
Read the 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).
- Conditions
- Lymphedema
- Being tested
- phlebotomy
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phlebotomyProcedure or surgery
Also called venipuncture
phlebotomy for collection of plasma and serum, ~30 cc
| Study group | Role | What they receive |
|---|---|---|
| Cohort with lymphedema | Participants with a history of acquired lymphedema of at least 6 months' duration, will have phlebotomy for serum and plasma. Receives: Procedure: phlebotomy | |
| Cohort without lymphedema | Healthy volunteers; will have phlebotomy for serum and plasma. Receives: Procedure: phlebotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers for the Detection of Lymphatic Vascular Insufficiency
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startSep 2009
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanley Rockson, Stanford University
- Investigators
- Stanley G Rockson, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375165
- Sponsor's protocol ID
- 17690
- Acronym
- Biomarkers
- Status last verified
- Nov 2023
- First submitted
- 24 Feb 2015
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: to be determined
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for the Detection of Lymphatic Insufficiency
- ClinicalTrials.gov ID
- NCT02375165
- Acronym / sponsor ID
- Biomarkers / 17690
- Conditions
- Lymphedema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort with lymphedema | – | Procedure: phlebotomyParticipants with a history of acquired lymphedema of at least 6 months' duration, will have phlebotomy for serum and plasma. |
| Cohort without lymphedema | – | Procedure: phlebotomyHealthy volunteers; will have phlebotomy for serum and plasma. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- clinical diagnosis of lymphedema of at least 6 months' duration
- no evidence of lymphedema
Key exclusion criteria (14 listed)
- active cancer
- infection
- bleeding tendency
- active coronary artery disease
- congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phlebotomyAlso: venipuncturephlebotomy for collection of plasma and serum, ~30 cc | Procedure or surgery | Cohort with lymphedema, Cohort without lymphedema |
Primary outcome
Biomarkers for the Detection of Lymphatic Vascular Insufficiency
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Yes. to be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley G Rockson, MD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers for the Detection of Lymphatic Vascular Insufficiency (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.