RECRUITING

A Prospective Natural History Study of Lymphatic Anomalies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective Natural History Study of Lymphatic Anomalies

Quick Facts

Study Start:2023-03-20
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05731141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Current or history of lymphatic anomaly or symptoms suggestive of a lymphatic disorder Or
  2. * An ill-defined vascular anomaly that is suspected to have an abnormal lymphatic component Or
  3. * A pathogenic, likely pathogenic, or VUS in a genetic disorder with a known lymphatic component Or
  4. * Clinical diagnosis of a syndrome with a known lymphatic component
  1. * Any condition, in the opinion of the investigator, that would increase risk of participation or impair their ability to comply with protocol requirements.
  2. * 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.

Contacts and Locations

Study Contact

Andrea I Bowling, C.R.N.P.
CONTACT
(301) 451-3824
nichd_lymphaticanoma@mail.nih.gov
Sarah E Sheppard, M.D.
CONTACT
(240) 578-5047
sarah.sheppard@nih.gov

Principal Investigator

Sarah E Sheppard, M.D.
PRINCIPAL_INVESTIGATOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Sarah E Sheppard, M.D., PRINCIPAL_INVESTIGATOR, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-20
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2023-03-20
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Protein Losing Enteropathy
  • Lymphedema
  • Lymphangiectasia
  • Kaposiform Lymphangiomatosis
  • Gorham Stout Disease
  • Generalized Lymphatic Anomaly
  • Complex Lymphatic Anomaly
  • Chylous Effusion
  • Chylous Ascites
  • Central Conducting Lymphatic Anomaly

Additional Relevant MeSH Terms

  • Lymphatic Diseases
  • Lymphatic Abnormalities