Lymphatic Anomalies Registry

Why are we doing this research?

The goal of this research study is to better understand rare vascular tumors and malformations. There is little information available about the long-term effects of these lesions or the most effective treatments. We are conducting a research study to better understand these vascular lesions. We aim to describe the long-term outcomes and identify which treatments are the most effective through a structured interview with you and review of records from your medical providers, as well as conducting annual follow-up questionnaires.

Who can participate?

We are approaching all patients and parent/guardian(s) of patients with vascular malformations, tumors or overgrowth syndromes with a significant lymphatic component. We anticipate 1000 participants in this study. The total enrolled at CCHMC is expected to be approximately 350 per year.

Conditions

Hematology - Hemangioma and Vascular Malformation

What will happen in the study?

Your participation in this research project initially will involve a structured questionnaire. During the interview you will be asked questions about your vascular lesion. The questions focus on past and current symptoms you have had related to the vascular lesion. We will also ask about past and current medical and surgical treatments that you have had.

In addition to the questionnaire, we request permission to contact the primary doctor managing the vascular lesion for additional information. The information we will request is limited to information about the vascular lesion. Specifically, we are interested in blood test results, imaging reports, pathology reports, and details of specific medical and surgical treatments administered.

Major questions in this field about response to therapies and long-term outcomes have been difficult to answer, since many patients are lost to follow-up (move away, change doctors, etc.). To improve our answers to these questions, we would like to be able to follow up with you yearly, with a short questionnaire (about 10-20 minutes) regarding the ongoing management of your vascular anomaly. This will continue until you choose to withdraw from the study or are lost to follow-up.

You may choose to participate in the initial questionnaire and gathering of data from your physician without choosing to be contacted every year. In addition, you may ask to be removed from the follow-up portion of this study at any point in the future.

The data collected from both the initial questionnaire and the annual follow-up will include lesion features, symptoms, laboratory values, outcome measures, and functionality scores. Data will be housed at Boston Children's Hospital. Your data is always available to the center that referred you to our study. For research, de-identified data (without your name, date of birth, etc.) may be shared with other institutions.

What are the good things that can happen from this research?

If you agree to take part in this study, there will be no direct medical benefit to you. We hope that the information learned from this study will improve the care of patients with your condition in the future.

What are the bad things that can happen from this research?

The focus of this study is the collection of information on past events and treatment. There are no exams, blood draws, or procedures that will be conducted as part of this study. The only risks from this study are breach of confidentiality to your medical information and, possibly, feeling uncomfortable talking about your experience with vascular anomaly care. If at any time you would like to skip a question or terminate the interview, we will respect your request. While we will take precautions to maintain the privacy of your personal health information [as detailed below], there is always the risk of unintentional loss of privacy during the process of requesting, storing or transporting this information.

Will you/your child be paid to be in this research study?

There will not be any compensation for participation in this study.

Clinical Trials / Research Studies
Clinical Trials / Research Studies