Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT02399527

Conditions

Lymphatic Malformation

Generalized Lymphatic Anomaly (GLA)

Central Conducting Lymphatic Anomaly

CLOVES Syndrome

Gorham-Stout Disease ("Disappearing Bone Disease")

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Lymphatic Malformation

Generalized Lymphatic Anomaly (GLA)

Central Conducting Lymphatic Anomaly

CLOVES Syndrome

Gorham-Stout Disease ("Disappearing Bone Disease")

Study ID

NCT02399527

Start date

Jun, 2013

Status verified date

Apr, 2026

Completion date

Jun, 2035

Anticipated

Primary completion date

Jun, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kelsey Deemer, BS

617-355-5226Lymphaticregistry@childrens.harvard.edu

Meghan O'Hare, CPNP

617-355-5226Lymphaticregistry@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Meghan O'Hare, CPNP

617-355-5226Lymphaticregistry@childrens.harvard.edu

Kelsey Deemer

617-355-5226Lymphaticregistry@childrens.harvard.edu

Principal Investigator:

Melisa Ruiz-Gutierrez, M.D.

More Information

Sponsor

Boston Children's Hospital

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • Vascular Anomalies
  • Lymphatic Anomalies
  • Lymphatic Malformation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-04-24.