RecruitingNot Applicable

Lymphatic Anomalies Registry for the Assessment of Outcome Data

United States1,000 participantsStarted 2013-06

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical diagnosis of complex vascular tumor, malformation or overgrowth syndrome with significant lymphatic component

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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.

Timeframe: 15 years

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

Timeframe: 15 years

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

Timeframe: 15 years

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

Timeframe: 15 years

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

Timeframe: 15 years

Trial details

NCT IDNCT02399527

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2035-06

Contact for this trial

Kelsey Deemer, BS

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

View on ClinicalTrials.gov More Lymphatic Malformation trials

Plain-language summary

What they're measuring

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

Timeframe: 15 years

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

Timeframe: 15 years

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

Timeframe: 15 years

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

Timeframe: 15 years

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

Timeframe: 15 years