HLH Patients - a Retrospective Study | NCT05531721

Studies
HLH Patients - a Retrospective Study

NCT05531721

Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Status

Completed

Last Update Posted

May 25, 2023Actual

Enrollment

39Actual

Phase

Not provided

Conditions

Hemophagocytic Lymphohistiocytoses

Interventions

Observation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2022Actual

Primary Completion Date

Feb 24, 2023Actual

Completion Date

Apr 30, 2023Actual

First Submitted Date

Aug 19, 2022

First Submission Date that Met QC Criteria

Sep 7, 2022

First Posted Date

Sep 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2023

Last Update Posted Date

May 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Franca Fagioli, Clinical Professor, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pediatric patients affected by hemophagocytic lymphohistiocytoses		pediatric patients with HLH	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	Observation and retrospective data collection	pediatric patients affected by hemophagocytic lymphohistiocytoses

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

pediatric patients with HLH

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Franca Fagioli, MD	AOU Città della Salute e della Scienza di Torino - OIRM	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita		Turin		10126	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051359	Lymphohistiocytosis, Hemophagocytic

Ancestor Terms

ID	Term
D015616	Histiocytosis, Non-Langerhans-Cell
D015614	Histiocytosis
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided