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NCT Number: NCT02399527

Lymphatic Anomalies Registry for the Assessment of Outcome Data

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.

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Key information

Conditions

Lymphatic Malformation Angiomatosis Blue Rubber Bleb Nevus Syndrome Bone Diseases Bone Diseases, Developmental Bone Resorption CLOVES Syndrome Cardiovascular Abnormalities Cardiovascular Diseases Central Conducting Lymphatic Anomaly Congenital Abnormalities Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi Congenital, Hereditary, and Neonatal Diseases and Abnormalities Generalized Lymphatic Anomaly (GLA) Gorham-Stout Disease ("Disappearing Bone Disease") Hemic and Lymphatic Diseases Kaposiform Hemangioendothelioma Kaposiform Hemangioendothelioma/Tufted Angioma Kaposiform Lymphangiomatosis Klippel-Trenaunay Syndrome Klippel-Trenaunay-Weber Syndrome Lymphangiomatosis Lymphatic Abnormalities Lymphatic Diseases Musculoskeletal Diseases Osteolysis Osteolysis, Essential Tufted angioma Vascular Diseases Vascular Malformations

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of complex vascular tumor, malformation or overgrowth syndrome with significant lymphatic component

Treatment and study plan

Primary outcomes

  1. To characterize the heterogeneity of lymphatic disorders, including demographics, presentation, and complications.

    Time frame: 15 years

  2. 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

  3. To identify factors prognostic of poor outcome and use them to develop "staging" of lymphatic anomalies.

    Time frame: 15 years

  4. To describe the natural history of lymphatic anomalies, including morbidity and mortality.

    Time frame: 15 years

  5. To describe the therapies (medical and procedural), adverse events and responses to therapy in patients with lymphatic anomalies.

    Time frame: 15 years

  6. To pilot quality of life, functional assessment and pain scoring tools in this patient population.

    Time frame: 15 years

Secondary outcomes

  1. To estimate the proportion of time that patients with lymphatic anomalies have affected offspring.

    Time frame: 15 years

  2. To assess for correlations of pregnancy complications or medications taken during pregnancy with the development of lymphatic anomalies.

    Time frame: 15 years

Study contacts

Contact information is provided by the study sponsor or research team.

Kelsey Deemer, BS

CONTACT

[email protected]

617-355-5226

Meghan O'Hare, CPNP

CONTACT

[email protected]

617-355-5226

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Lymphatic Malformation Institute

Registry information

Important dates

Study start
2013
Primary completion
2035
Study completion
2035
First posted
Mar 26, 2015
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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