International Lymphatic Disease and Lymphedema Registry

Lymphedema Clinical Trial

Official title:

The International Lymphatic Disease and Lymphedema Patient Registry and Biorepository

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01336790
• Other study ID #: SU-04052011-7662
• Secondary ID: 16384
• Status: Recruiting
• Start date: March 2009
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: Stanley Rockson, MD
• Phone: (650) 7231396
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Presence of lymphatic disease

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Lymphatic Diseases
• Lymphedema

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Lymphatic Education & Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of lymphatic disease		15 years
Secondary	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.	15 years

External Links

•   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.