HLH Patients - a Retrospective Study

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05531721
• Other study ID #: HLH-OIRM
• Status: Completed
• Start date: November 10, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Monocentric, observational, retrospective, no profit study aimed to analyze factors that are significantly impacting the outcome of patients diagnosed with HLH.

Description:

retrospective data collection to study: type of HLH familial vs secondary, sex, age, presence of infectious cause, involvement central nervous system ( SNC), hepatic involvement, presence of hemophagocytosis, presence of splenomegaly, presence of involvement of other organs, the value of neutrophils (PMN), the value of hemoglobin, platelets, albumin, triglycerides, ferritin, LDH, type of therapy and the response to therapy after 2 months

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hemophagocytic Lymphohistiocytoses
• Lymphohistiocytosis, Hemophagocytic

Intervention

Other:
• Observation
Observation and retrospective data collection

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Country where clinical trial is conducted

Italy, 

Outcome

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