LymphedemaNCT01336790
International Lymphatic Disease and Lymphedema Registry
An observational study of Lymphedema, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the International Lymphatic Disease and Lymphedema Patient Registry and Biorepository is to collect health information in order to study the disease classification, natural history, and impact of Lymphatic Disease, Lymphedema and Related Disorders and its treatments and medical outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphedema
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants (national and international participants) with the presence of lymphatic disease.
Who may be able to join
- Presence of lymphatic disease
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Stanley Rockson, MD contact
United States1 site, 1 recruiting
- Recruiting
Stanford University School of Medicine
Stanford, California, 94305
Principal Investigator
Stanley G Rockson
About this study
Official title: The International Lymphatic Disease and Lymphedema Patient Registry and Biorepository
The purpose of the International Lymphatic Disease and Lymphedema Patient Registry and Biorepository is to collect health information in order to study the disease classification, natural history, and impact of Lymphatic Disease, Lymphedema and Related Disorders and its treatments and medical outcomes.
Read the detailed description
This project represents the inauguration of an International Patient Registry for Lymphatic Diseases. This project will be completed through an affiliation with the Lymphatic Education \& Research Network, a non-profit organization whose mission is to promote research and the development of new therapies for patients with lymphatic diseases, including lymphedema. The registry will provide researchers with much-needed clinical data to study the impact of diseases of the lymphatic system, in order to develop improved treatments and find a cure for lymphatic diseases, lymphedema, and related disorders. The establishment of this initiative is a major step forward in research for direct study of groups of patients with lymphatic disease. In the future, this project will be able to be linked with a biorepository, in which tissue and blood samples derived from patients will be made available for research into human disease states. An international patient registry and tissue/cell bank program paves the way for future clinical trials of experimental drugs and therapies designed to treat lymphatic disease in human subjects.
- Conditions
- Lymphedema
- Keywords
- Lymphatic disease, Lymphedema, Lymphangiomatosis, Lymphangiectasia, Protein-losing enteropathy, Vascular Anomalies
- Medical subject headings
- Lymphedema, Lymphatic Diseases, Lymphangiectasis, Protein-Losing Enteropathies, Vascular Malformations
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of lymphatic disease
Measured: 15 years
Secondary outcomes (1)
socioeconomic impact of lymphatic disease
The data in the registry will be utilized to determine the financial impact of requisite diagnostic and treatment interventions and will be analyzed to consider the relative contribution of third-party payer participation in the cost of care. The financial impact of disease and treatment will be addressed through the financial data entered by registry participants.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startMar 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
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Lymphatic Education & Research Network
- Responsible party
- Principal investigator, Stanley Rockson, Stanford University
- Investigators
- Stanley G Rockson, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336790
- Sponsor's protocol ID
- SU-04052011-7662
- Other IDs
- 16384
- Status last verified
- Nov 2023
- First submitted
- 7 Apr 2011
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: grouped data may be shared
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
- The International Lymphatic Disease and Lymphedema Patient Registry and Biorepository
- ClinicalTrials.gov ID
- NCT01336790
- Acronym / sponsor ID
- SU-04052011-7662
- Conditions
- Lymphedema
- Keywords
- Lymphatic disease, Lymphedema, Lymphangiomatosis, Lymphangiectasia, Protein-losing enteropathy, Vascular Anomalies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Lymphatic Education & Research Network
- Study start
- Mar 2009
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Apr 2011 (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.
The purpose of the International Lymphatic Disease and Lymphedema Patient Registry and Biorepository is to collect health information in order to study the disease classification, natural history, and impact of Lymphatic Disease, Lymphedema and Related Disorders and its treatments and medical outcomes.
Detailed description
This project represents the inauguration of an International Patient Registry for Lymphatic Diseases. This project will be completed through an affiliation with the Lymphatic Education \& Research Network, a non-profit organization whose mission is to promote research and the development of new therapies for patients with lymphatic diseases, including lymphedema. The registry will provide researchers with much-needed clinical data to study the impact of diseases of the lymphatic system, in order to develop improved treatments and find a cure for lymphatic diseases, lymphedema, and related disorders. The establishment of this initiative is a major step forward in research for direct study of groups of patients with lymphatic disease. In the future, this project will be able to be linked with a biorepository, in which tissue and blood samples derived from patients will be made available for research into human disease states. An international patient registry and tissue/cell bank program paves the way for future clinical trials of experimental drugs and therapies designed to treat lymphatic disease in human subjects.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants (national and international participants) with the presence of lymphatic disease.
Key inclusion criteria (1 listed)
- Presence of lymphatic disease
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of lymphatic disease
Time frame: 15 years
1 secondary outcome
socioeconomic impact of lymphatic disease
Time frame: 15 years
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.
- The International Lymphatic Disease Patient Registry will serve as a repository of information that will enhance the future ability of health care professionals to accurately identify, categorize, treat and prevent lymphatic disease.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. grouped data may be shared
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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 Rockson, MD contact
Stanley G Rockson principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema, run by Stanford University at 1 site in United States.
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 1 inclusion and 1 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Stanley Rockson, MD ((650) 7231396), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of lymphatic disease (time frame: 15 years). 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.