HLH Patients - a Retrospective Study

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)

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

Study Overview

• Status: Completed
• Conditions: Hemophagocytic Lymphohistiocytoses
• Intervention / Treatment: Other: Observation

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

pediatric patients with HLH

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pediatric patients affected by hemophagocytic lymphohistiocytoses; pediatric patients with HLH	Other: Observation; Observation and retrospective data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
• Investigators: Principal Investigator: Franca Fagioli, MD, AOU Città della Salute e della Scienza di Torino - OIRM

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): February 24, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphohistiocytosis, Hemophagocytic
• Other Study ID Numbers: HLH-OIRM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No