A multi-step approach to overcome challenges in the management of head and neck lymphatic malformations, and response to treatment.
Valentina Trevisan, Eugenio De Corso, Germana Viscogliosi...
https://pubmed.ncbi.nlm.nih.gov/39044220Actively Recruiting
Phase Not Applicable
Age: 0 - 100Years
All Genders
ID06892964
Prospective and Retrospective Clinical Study of Lymphatic Malformations with Registry and Biobank for Biological Sample Collection in Italy
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-25
70
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lymphatic malformations (ML) are rare, benign conditions caused by abnormal development of the lymphatic system, often appearing at birth or early childhood mainly in the head and neck regions. These malformations can lead to serious complications such as airway blockage, eating difficulties, and bleeding. Due to their complexity and rarity, patients often require care from specialized centers. Recently, genetic discoveries have opened new possibilities for personalized treatments, highlighting the need for improved national protocols and research collaboration. This study aims to create a national computerized registry and biobank in Italy to collect both retrospective and prospective clinical and biological data from patients with ML. Genetic profiling using targeted next-generation sequencing (NGS) panels will be performed on tissue samples from affected patients. The study will gather extensive information on different ML types, their genetic profiles, treatment outcomes, and evolution over time. Participants will provide clinical data and biological samples for research purposes, with long-term follow-up planned over 20 years. Researchers will evaluate the incidence and prevalence of ML, genotype-phenotype relationships, treatment effects, quality of life, and natural disease progression. This comprehensive approach supports the development of national care standards and promotes scientific advances in ML management.
CONDITIONS
Brief Title
Institution of an Italian Registry and Biobank for Biological Sample Collection
Who Can Participate
Age: 0 - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 0 to 100 years
- Signed informed consent
- Individuals with any type of lymphatic malformation (isolated, syndromic, congenital, or acquired) diagnosed by participating centers
You will not qualify if you...
- Patients whose clinical condition does not meet the inclusion criteria as assessed by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Genetic Profiling
Duration - Up to 20 years
Participants undergo genetic profiling using tissue samples to analyze DNA and characterize genotype-phenotype associations.
Visits as needed for sample collection and assessments
Long-term Monitoring
Duration - Up to 20 years
Participants are observed over the long term to evaluate the natural evolution of lymphatic malformations, outcomes of various treatments, and quality of life changes.
Periodic visits over 20 years depending on treatment and follow-up needs
Trial Site Locations
Total: 1 location
1
Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS
Roma, Italy, 00168
Actively Recruiting
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Research Team
C
Chiara Leoni, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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