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Lymphatic Anomalies Registry for the Assessment of Outcome Data

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. Identifier: NCT02399527
Recruitment Status : Recruiting
First Posted : March 26, 2015
Last Update Posted : April 6, 2021
Lymphatic Malformation Institute
Information provided by (Responsible Party):
Melisa Ruiz-Gutierrez, Boston Children's Hospital

Tracking Information
First Submitted Date March 17, 2015
First Posted Date March 26, 2015
Last Update Posted Date April 6, 2021
Actual Study Start Date June 2013
Estimated Primary Completion Date June 2035   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 21, 2015)
  • To characterize the heterogeneity of lymphatic disorders, including demographics, presentation, and complications. [ Time Frame: 15 years ]
  • To identify factors that are prognostic of the occurrence of complications, including effusions, coagulopathy, ectatic draining veins, prior infections, visceral involvement, bone involvement, and development of cardiopulmonary symptoms. [ Time Frame: 15 years ]
  • To identify factors prognostic of poor outcome and use them to develop "staging" of lymphatic anomalies. [ Time Frame: 15 years ]
  • To describe the natural history of lymphatic anomalies, including morbidity and mortality. [ Time Frame: 15 years ]
  • To describe the therapies (medical and procedural), adverse events and responses to therapy in patients with lymphatic anomalies. [ Time Frame: 15 years ]
  • To pilot quality of life, functional assessment and pain scoring tools in this patient population. [ Time Frame: 15 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 21, 2015)
  • To estimate the proportion of time that patients with lymphatic anomalies have affected offspring. [ Time Frame: 15 years ]
  • To assess for correlations of pregnancy complications or medications taken during pregnancy with the development of lymphatic anomalies. [ Time Frame: 15 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Lymphatic Anomalies Registry for the Assessment of Outcome Data
Official Title Lymphatic Anomalies Registry for the Assessment of Outcome Data
Brief Summary Lymphatic anomalies are a rare subset of vascular anomalies that are poorly understood. the understanding of the natural history, long-term outcomes, risk factors for morbidity and mortality, and the relative benefit of medical therapies and procedures is limited.The goal of this project is to better understand these diseases and improve the care of theses rare patients. To do this, the investigators are conducting an observational study of patients with lymphatic anomalies, including an annual follow-up questionnaire to gather prospective data on mortality, morbidity, treatments, and functionality as well as quality of life.
Detailed Description The purpose of the Lymphatic Anomalies Registry, created at Boston Children's Hospital, is to create a database to help current and future patients diagnosed with a lymphatic anomaly. The ultimate goal of the registry is to better understand and predict responses to therapies and risk factors for complications. Although the Lymphatic Anomalies Registry exists at Boston Children's Hospital, patients can be entered into the registry regardless of whether or not they visit Boston Children's Hospital, thus increasing the program's accessibility. The Lymphatic Anomalies Registry includes patients who have vascular anomalies with a lymphatic component across various diagnoses. From the patient's perspective, participation in the Lymphatic Anomalies Registry means taking part in a short, thirty minute interview, and providing the registry with access to medical records. The interview is conducted verbally with study staff of the Lymphatic Anomalies Registry, and can take place either at the hospital, or over the phone. During the interview, the registry will inquire about the patient's diagnosis, disease features, medical therapies, and procedures. Interested prospective patients will receive an introductory packet from the registry with information on how to proceed in the registry process. All obtained patient information is housed on a secure, HIPPA compliant, internal database, managed by Boston Children's Hospital staff. Patient information entered into the external database is de-identified. The research teams will also obtain a medical record release form to request the patient's medical record for review in our study.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 15 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Both domestic and international patients with complex lymphatic anomalies, as described above, are eligible to participate. Travel to Boston is not required for participation. Eligible patients are identified through active referral in the Vascular Anomalies Center at Boston Children's Hospital. Physicians and patients may also refer eligible patients directly to the Lymphatic Anomalies Registry. Patients may indicate interest in participation themselves by contacting the registry team through the "Contact Us" link on
  • Lymphatic Malformation
  • Generalized Lymphatic Anomaly (GLA)
  • Central Conducting Lymphatic Anomaly
  • CLOVES Syndrome
  • Gorham-Stout Disease ("Disappearing Bone Disease")
  • Blue Rubber Bleb Nevus Syndrome
  • Kaposiform Lymphangiomatosis
  • Kaposiform Hemangioendothelioma/Tufted Angioma
  • Klippel-Trenaunay Syndrome
  • Lymphangiomatosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 21, 2015)
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2035
Estimated Primary Completion Date June 2035   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of complex vascular tumor, malformation or overgrowth syndrome with significant lymphatic component
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contact: Parker Greiwe, BS 617-355-6863
Contact: Meghan O'Hare, CPNP 617-355-5226
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT02399527
Other Study ID Numbers P00007182
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Melisa Ruiz-Gutierrez, Boston Children's Hospital
Study Sponsor Boston Children's Hospital
Collaborators Lymphatic Malformation Institute
Principal Investigator: Melisa Ruiz-Gutierrez, M.D. Boston Children's Hospital
PRS Account Boston Children's Hospital
Verification Date April 2021