NCT05531721

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

August 19, 2022

Last Update Submit

May 23, 2023

Conditions

Hemophagocytic Lymphohistiocytoses

Outcome Measures

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);

    through study completion, an average of 1 year

Study Arms (1)

pediatric patients affected by hemophagocytic lymphohistiocytoses

pediatric patients with HLH

Other: Observation

Interventions

ObservationOTHER

Observation and retrospective data collection

pediatric patients affected by hemophagocytic lymphohistiocytoses

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

pediatric patients with HLH

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

Turin, 10126, Italy

Location

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

Observation

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-CellHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Franca Fagioli, MD

    AOU Città della Salute e della Scienza di Torino - OIRM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 19, 2022

First Posted

September 8, 2022

Study Start

November 10, 2022

Primary Completion

February 24, 2023

Study Completion

April 30, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)