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International Lymphatic Disease and Lymphedema Registry

This study is currently recruiting participants.
Verified October 2016 by Stanley Rockson, Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01336790
First Posted: April 18, 2011
Last Update Posted: October 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Feinstein Institute for Medical Research
Information provided by (Responsible Party):
Stanley Rockson, Stanford University
  Purpose
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
Lymphedema

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: The International Lymphatic Disease and Lymphedema Patient Registry and Tissue Bank

Resource links provided by NLM:


Further study details as provided by Stanley Rockson, Stanford University:

Primary Outcome Measures:
  • prevalence of lymphatic disease [ Time Frame: 15 years ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 5000
Study Start Date: March 2009
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336790


Contacts
Contact: Leslie Roche, RN/BSN (650) 454-7276 lesroche@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Leslie Roche, RN/BSN    650-454-7276    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

Additional Information:
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 Submitted: April 7, 2011
First Posted: April 18, 2011
Last Update Posted: October 17, 2016
Last Verified: October 2016
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