Hemophagocytic LymphohistiocytosesNCT05531721
HLH Patients - a Retrospective Study
An observational study of Hemophagocytic Lymphohistiocytoses, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna at 1 site in Italy.
Trial summary
Monocentric, observational, retrospective, no profit study aimed to analyze factors that are significantly impacting the outcome of patients diagnosed with HLH. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hemophagocytic Lymphohistiocytoses
- What is being tested?
- Observation
- How many people
- 39 participants
- Where
- 1 siteItaly
- Study dates
- 10 Nov 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients with HLH
Who may be able to join
- 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
Who cannot join
- The study does not foresee specific exclusion criteria other than the non-compliance with the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
Turin, 10126
About this study
Official 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)
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
- Conditions
- Hemophagocytic Lymphohistiocytoses
- Being tested
- Observation
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation and retrospective data collection
| Study group | Role | What they receive |
|---|---|---|
| pediatric patients affected by hemophagocytic lymphohistiocytoses | pediatric patients with HLH Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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);
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start10 Nov 2022
- Primary completion24 Feb 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophagocytic LymphohistiocytosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Franca Fagioli, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Investigators
- Franca Fagioli, MD, Principal investigator, AOU Città della Salute e della Scienza di Torino - OIRM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531721
- Sponsor's protocol ID
- HLH-OIRM
- Status last verified
- May 2023
- First submitted
- 19 Aug 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05531721
- Acronym / sponsor ID
- HLH-OIRM
- Conditions
- Hemophagocytic Lymphohistiocytoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric patients affected by hemophagocytic lymphohistiocytoses | – | Other: Observationpediatric patients with HLH |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients with HLH
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- The study does not foresee specific exclusion criteria other than the non-compliance with the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObservation and retrospective data collection | Other | pediatric patients affected by hemophagocytic lymphohistiocytoses |
Primary outcome
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);
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franca Fagioli, MD principal investigator
AOU Città della Salute e della Scienza di Torino - OIRM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophagocytic Lymphohistiocytoses, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological parameter that are significantly impacting the outcome of patients diagnosed with HLH (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.