Hemophagocytic Lymphohistiocytoses Clinical Trial
Official title:
Retrospective Analysis of the Outcome of Patients Diagnosed With Hemophagocytic Lymphohistiocytosis (HLH) Treated at the S.C.Pediatric Oncohematology of the Regina Margherita Torino Hospital (OIRM)
NCT number | NCT05531721 |
Other study ID # | HLH-OIRM |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 10, 2022 |
Est. completion date | April 30, 2023 |
Verified date | May 2023 |
Source | Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Monocentric, observational, retrospective, no profit study aimed to analyze factors that are significantly impacting the outcome of patients diagnosed with HLH.
Status | Completed |
Enrollment | 39 |
Est. completion date | April 30, 2023 |
Est. primary completion date | February 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria: - Have received HLH diagnosis according to HLH 2004 criteria - age ?18 years. - followed at our facility between January 2004 and December 2021 - Whose parents have consented to participation and data processing Exclusion Criteria: - The study does not foresee specific exclusion criteria other than the non-compliance with the inclusion criteria |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita | Turin |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | physiological parameter that are significantly impacting the outcome of patients diagnosed with HLH | Type of HLH (familial vs secondary); sex (M or F); age (in year); presence of infectious cause; involvement central nervous system (yes or no); hepatic involvement (yes or no); presence of hemophagocytosis (yes or no); presence of splenomegaly (yes or no); involvement of other organs (yes or no); value of neutrophils (PMN, in 10^9/L), hemoglobin (in g/dL), platelets (in 10^9/L), albumin (in g/L), triglycerides (in mg/dL), ferritin (in UI/L) and LDH (in UI/L); | through study completion, an average of 1 year |
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