NCT05731141 A Prospective Natural History Study of Lymphatic Anomalies
| NCT ID | NCT05731141 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Condition | Lymphatic Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2023-03-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2023-03-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: The lymphatic system is a network of vessels that carry a clear fluid called lymph through the body. Problems in the lymphatic system can cause pain, fluid buildup, and issues with immunity. There is much researchers do not understand about lymphatic anomalies. In this natural history study, they will collect data from a lot of people over a long time. Objective: To better understand why lymphatic anomalies develop. The goal is to improve future treatments. Eligibility: People aged 0 days and older with a suspected or confirmed lymphatic anomaly. Their unaffected parents or siblings aged 7 years or older are also needed. Design: Participants may remain in the study indefinitely. Affected participants may be evaluated every 10 months to 2 years. Some participants will be seen over telemedicine. Others will be seen at the NIH Clinical Center for 2-5 days. All participants will have a physical exam. They may provide specimens including blood, saliva, hair follicles, stool, skin, and other tissues. Samples may be used for genetic testing. Participants may undergo other tests depending on their medical conditions. The NIH Clinical Center visit may include: Heart tests include placing stickers on the chest to measure electrical activity and using sound waves to capture pictures of the heart. A lung test measures the muscle strength in the chest. Participants will blow into a tube. Photographs may be taken of participants faces and other features. Imaging scans will take pictures of the inside of the body. One scan will measure bone density. One type of scan tracks how lymph fluid moves through the body. Participants will be under anesthesia, and they will be injected with a dye.
Eligibility Criteria
* INCLUSION CRITERIA: Affected (Proband) In order to be eligible to participate in this study, an individual must meet one of the following criteria as determined after review of medical history: * Current or history of lymphatic anomaly or symptoms suggestive of a lymphatic disorder Or * An ill-defined vascular anomaly that is suspected to have an abnormal lymphatic component Or * A pathogenic, likely pathogenic, or VUS in a genetic disorder with a known lymphatic component Or * Clinical diagnosis of a syndrome with a known lymphatic component Unaffected (First Degree Relatives: Parents and Siblings) Genetic variants underlying complex lymphatic anomalies can be passed down through parents or be new in a child (de novo). Inclusion of first-degree relatives will assist in genetic analysis to delineate whether the variant is inherited or de novo. To be eligible to participate as a first degree relative in this study, an individual must be a first-degree family member of an affected participants EXCLUSION CRITERIA: Affected Proband An individual who meets any of the following criteria will be excluded from participation in this study after review of medical history, concomitant medication and allergy review, anthropometrics, and performance status: -Any condition, in the opinion of the investigator, that would increase risk of participation or impair their ability to comply with protocol requirements. Lymphatic anomalies that are definitively determined to be secondary by the principal investigator will be excluded from this study. For example, participants who develop a lymphedema after breast cancer surgery. Unaffected (First Degree Relatives) -Any condition, in the opinion of the investigator, that would increase risk of participation or impair their ability to comply with protocol requirements.
Contact & Investigator
Sarah E Sheppard, M.D.
PRINCIPAL INVESTIGATOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Frequently Asked Questions
Who can join the NCT05731141 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 100 Years, studying Lymphatic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05731141 currently recruiting?
Yes, NCT05731141 is actively recruiting participants. Contact the research team at nichd_lymphaticanoma@mail.nih.gov for enrollment information.
Where is the NCT05731141 trial being conducted?
This trial is being conducted at Bethesda, United States, Philadelphia, United States.
Who is sponsoring the NCT05731141 clinical trial?
NCT05731141 is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The principal investigator is Sarah E Sheppard, M.D. at Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The trial plans to enroll 1,200 participants.