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OpenTrials
Completed

NCT Number: NCT05531721

HLH Patients - a Retrospective Study

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

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Key information

Conditions

Hemophagocytic Lymphohistiocytoses Hemic and Lymphatic Diseases Histiocytosis Histiocytosis, Non-Langerhans-Cell Lymphatic Diseases Lymphohistiocytosis, Hemophagocytic

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Turin, 10126, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

Observation and retrospective data collection

Primary outcomes

  1. physiological parameter that are significantly impacting the outcome of patients diagnosed with HLH

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

    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);

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Other

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2022
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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