Registry and biobank for lymphatic malformations in Italy
Prospective and Retrospective Clinical Study of Lymphatic Malformations: Institution of an Italian REGistry of Lymphatic Malformations and of a Biobank for Biological Sample Collection
This study is creating a registry and biobank to collect information and samples from people with lymphatic malformations in Italy to improve understanding and treatment of these rare conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | N/A to 100 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06892964 on ClinicalTrials.gov |
What this trial studies
This initiative aims to establish a comprehensive registry and biobank for patients with lymphatic malformations (ML) in Italy. It will collect biological samples and clinical data to enhance understanding of ML, including genotype-phenotype associations and the evolution of these conditions over time. The study will also evaluate treatment outcomes and quality of life for affected individuals, while aiming to create a nationally shared diagnostic approach for ML. By gathering this data, the project seeks to improve the management and treatment of patients with these rare conditions.
Who should consider this trial
Good fit: Ideal candidates for this study include individuals of any age with any type of lymphatic malformation, whether isolated or syndromic.
Not a fit: Patients whose clinical presentation does not align with the inclusion criteria for lymphatic malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this project could lead to improved diagnosis, treatment strategies, and overall management of lymphatic malformations.
How similar studies have performed: While the establishment of registries and biobanks is a common approach in rare disease research, this specific initiative is novel in its focus on lymphatic malformations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 0-100 years 2. Signed informed consent. 3. Individuals with any type of ML (isolated, syndromic, congenital or acquired, with or without molecular confirmation) identified by participating centers Exclusion Criteria: * Patients whose clinical picture is not compatible with points a) (b) and (c) of the inclusion criteria, as assessed by the Investigator.
Where this trial is running
Roma
- Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Chiara Leoni — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Chiara Leoni, MD, PhD
- Email: chiara.leoni@policlinicogemelli.it
- Phone: 00063381344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.