CClinicalTrials.gg
CompletedNCT05531721Updated May 25, 2023

HLH Patients - a Retrospective Study

An observational study in Hemophagocytic Lymphohistiocytoses, sponsored by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna. Completed at 1 site in Italy. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2023-05-25.

Sponsored by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
39
Ages
Up to 18 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Hemophagocytic Lymphohistiocytoses
03

In context

Lymphohistiocytosis, Hemophagocytic

99 studies on the registry are indexed under Lymphohistiocytosis, Hemophagocytic; 36 are open to participants now.

This study's enrollment of 39 is below the median of 128 across 29 observational studies indexed under Lymphohistiocytosis, Hemophagocytic.

Browse Lymphohistiocytosis, Hemophagocytic studies →

Lead sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

pediatric patients with HLH

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

Exclusion Criteria:

  • The study does not foresee specific exclusion criteria other than the non-compliance with the inclusion criteria
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
39 participants (actual)
Patient registry
No

Groups and cohorts

  • pediatric patients affected by hemophagocytic lymphohistiocytoses

    pediatric patients with HLH

    Other: Observation

Interventions

  • OtherObservation

    Observation and retrospective data collection

06

What researchers measure

Primary outcomes

  1. 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);

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
    Turin, 10126, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05531721
Lead sponsor
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Responsible party
Prof. Franca Fagioli (Clinical Professor, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna) — Principal investigator
First posted
Sep 8, 2022
Start date
Nov 10, 2022
Primary completion
Feb 24, 2023
Completion
Apr 30, 2023
Last update
May 25, 2023

Study contacts

Franca Fagioli, MD
principal investigator · AOU Città della Salute e della Scienza di Torino - OIRM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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