A Non-Interventional National Study in Pediatric Patients With Unexplained Enlarged Spleen

Launched by SANOFI · Apr 12, 2021

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the causes of an enlarged spleen in children, specifically looking for cases of Gaucher disease and other related conditions. The study will involve children under 18 years old who have an enlarged spleen that doctors cannot easily explain after ruling out other common causes, such as infections or blood disorders. By participating, these young patients will help researchers gather important information about how often Gaucher disease occurs in this group and learn more about their health characteristics.

To be eligible for the study, children must be under 18 and have an enlarged spleen that has been checked for obvious problems. If a child has already been diagnosed with certain conditions, such as specific infections or blood cancers, they will not be included in this study. Participants can expect to undergo tests and examinations to help identify any underlying health issues. Overall, this research aims to improve understanding and diagnosis for children with unexplained spleen enlargement.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Patient under the age of 18 years
• • Patient with unexplained SMG (SMG defined as a palpable spleen, already known or discovered for the first time) and who has undergone tests to eliminate obvious causes of SMG
• Exclusion criteria:
• Patient with any obvious cause of SMG as described by clinical examination and/or lab or imaging test available in medical records and/or having been diagnosed with any of the following conditions:
• • 1. hemolytic anemia
• • 2. hematological malignancy
• • 3. portal hypertension
• • 4. infectious disease associated with SMG (Cytomegalovirus, Epstein Barr virus, leishmaniasis or other obvious infectious cause revealed by the medical history)
• • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.