International Lymphatic Disease and Lymphedema Registry

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of the National Lymphatic Disease and Lymphedema Registry 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.

Condition or disease
Lymphedema

Detailed Description:

This project represents the inauguration of a National Patient Registry for Lymphatic Diseases. This project will be completed through an affiliation with the Lymphatic Research Foundation, 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 tissue bank, in which tissue and blood samples derived from patients will be made available for research into human disease states. A national 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

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Study Type :	Observational
Estimated Enrollment :	5000 participants
Observational Model:	Case-Only
Time Perspective:	Other
Official Title:	The International Lymphatic Disease and Lymphedema Patient Registry and Tissue Bank
Study Start Date :	March 2009
Estimated Primary Completion Date :	December 2024
Estimated Study Completion Date :	December 2025

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. prevalence of lymphatic disease [ Time Frame: 15 years ]

Secondary Outcome Measures :

1. socioeconomic impact of lymphatic disease [ Time Frame: 15 years ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Participants (national and international participants) with the presence of lymphatic disease.

Criteria

Inclusion Criteria:

• Presence of lymphatic disease

Exclusion Criteria:

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Leslie Roche, RN/BSN	(650) 7231396	lesroche@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Leslie Roche, RN/BSN 650-723-1396 lesroche@stanford.edu
Principal Investigator: Stanley G Rockson

Sponsors and Collaborators

Stanford University

Feinstein Institute for Medical Research

Investigators

Principal Investigator:	Stanley G Rockson	Stanford University

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Tthe National Lymphatic Disease and Lymphedema 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/lymphedema. 

Responsible Party:	Stanley Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier:	NCT01336790 History of Changes
Other Study ID Numbers:	SU-04052011-7662; 16384 ( Other Identifier: Stanford IRB )
First Posted:	April 18, 2011
Last Update Posted:	March 2, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	grouped data may be shared

Keywords provided by Stanley Rockson, Stanford University:

Lymphatic disease; Lymphedema; Lymphangiomatosis	Lymphangiectasia; Protein-losing enteropathy; Vascular Anomalies

Additional relevant MeSH terms:

Lymphedema; Lymphatic Diseases