Hemophagocytic SyndromeNCT06614998
Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis a Multi-center, Prospective Study
An observational study of Hemophagocytic Syndrome, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
Our three-step screening system uses commonly used clinical and laboratory parameters to effectively identify patients who may be at high risk of HLH, conduct etiology screening early for patients who meet the diagnostic criteria for HLH, and guide standardized treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophagocytic Syndrome
- What is being tested?
- Patients diagnosed with HLH-94 should be treated as soon as possible
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 May 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A three-step screening process identified 80 people with suspected hemophagocytic syndrome
Who may be able to join
- Subjects must meet all of the following criteria:
- Patients who meet the first step screening + have ≥ 3 abnormal screening indicators in the second step
- Patients who meet the first step screening + have 2 abnormal screening indicators in the second step + patients with high-risk factors for HLH, such as history of lymphoma, EBV infection, autoimmune diseases, etc
Who cannot join
- Exclusion Criteria Subjects who meet one of the following criteria will not be enrolled: 1. Patients with liver cirrhosis, liver cancer, and hepatic encephalopathy 2. Patients with trauma, hepatosplenic rupture and other organ hemorrhage 3. Patients with severe disease such as shock, sepsis, and multiple organ failure 4. Patients with DIC 5. Patients with long-term anemia 6. Patients with acute promyelocytic leukemia 7. Patients with idiopathic deafness 8. Patients who have taken hormones/immunosuppressants 72 hours before admission 9. Hereditary fibrinogen deficiency
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affilitated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
Wei Sang, Docter, 13645207648, sw1981726@126.com
About this study
Official title: Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis: a Multi-center, Prospective Study
Our three-step screening system uses commonly used clinical and laboratory parameters to effectively identify patients who may be at high risk of HLH, conduct etiology screening early for patients who meet the diagnostic criteria for HLH, and guide standardized treatment. Therefore, this study proposes to establish a highly accurate and convenient hemophagocytic early warning system to improve the early diagnosis of patients with hemophagocytic syndrome and identify suspected HLH patients early. Etiology screening is performed on patients who meet the diagnostic criteria for HLH, high-risk predisposing factors are identified, and precise treatment is guided, thereby improving the success rate of patient treatment and improving the quality of life.
- Conditions
- Hemophagocytic Syndrome
- Being tested
- Patients diagnosed with HLH-94 should be treated as soon as possible
- Keywords
- hemophagocytic syndrome screening system
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients diagnosed with HLH-94 should be treated as soon as possibleDrug
For some highly suspicious patients, after diagnosis, according to the patient's etiology, the treatment plan should be determined as soon as possible, such as lymphoma-related patients treated with hormones combined with etoposide, which can greatly improve the prognosis of patients
| Study group | Role | What they receive |
|---|---|---|
| Screening patients with suspected hemophagocytic syndrome | Preliminary screening of patients with elevated ferritin and low fibrinogen, and then continue to improve triglycerides, abdominal color ultrasound and other examinations to further clarify, for some very suspicious patients, timely improve genes, NK cell activity and other tests, as soon as possible to determine whether they are patients with hemophagocytic syndrome Receives: Drug: Patients diagnosed with HLH-94 should be treated as soon as possible |
What is being measured
The primary outcome is the main question the study is designed to answer.
The suspected patient was diagnosed with hemophagocytic syndrome after complete NK cell activity, triglyceride tests, etc.
Measured: Time forecasting:2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 May 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophagocytic SyndromeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614998
- Sponsor's protocol ID
- XYFY2024-KL100-01
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis: a Multi-center, Prospective Study
- ClinicalTrials.gov ID
- NCT06614998
- Acronym / sponsor ID
- XYFY2024-KL100-01
- Conditions
- Hemophagocytic Syndrome
- Keywords
- hemophagocytic syndrome screening system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 26 Sep 2024 (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.
Our three-step screening system uses commonly used clinical and laboratory parameters to effectively identify patients who may be at high risk of HLH, conduct etiology screening early for patients who meet the diagnostic criteria for HLH, and guide standardized treatment. Therefore, this study proposes to establish a highly accurate and convenient hemophagocytic early warning system to improve the early diagnosis of patients with hemophagocytic syndrome and identify suspected HLH patients early. Etiology screening is performed on patients who meet the diagnostic criteria for HLH, high-risk predisposing factors are identified, and precise treatment is guided, thereby improving the success rate of patient treatment and improving the quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening patients with suspected hemophagocytic syndrome | – | Drug: Patients diagnosed with HLH-94 should be treated as soon as possiblePreliminary screening of patients with elevated ferritin and low fibrinogen, and then continue to improve triglycerides, abdominal color ultrasound and other examinations to further clarify, for some very suspicious patients, timely improve genes, NK cell activity and other tests, as soon as possible to determine whether they are patients with hemophagocytic syndrome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A three-step screening process identified 80 people with suspected hemophagocytic syndrome
Key inclusion criteria (3 listed)
- Patients who meet the first step screening + have ≥ 3 abnormal screening indicators in the second step
- Patients who meet the first step screening + have 2 abnormal screening indicators in the second step + patients with high-risk factors for HLH, such as history of lymphoma, EBV infection, autoimmune diseases, etc
Key exclusion criteria (1 listed)
- Exclusion Criteria Subjects who meet one of the following criteria will not be enrolled: 1. Patients with liver cirrhosis, liver cancer, and hepatic encephalopathy 2. Patients with trauma, hepatosplenic rupture and other organ hemorrhage 3. Patients with severe disease such as shock, sepsis, and multiple organ failure 4. Patients with DIC 5. Patients with long-term anemia 6. Patients with acute promyelocytic leukemia 7. Patients with idiopathic deafness 8. Patients who have taken hormones/immunosuppressants 72 hours before admission 9. Hereditary fibrinogen deficiency
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 |
|---|---|---|
| Patients diagnosed with HLH-94 should be treated as soon as possibleFor some highly suspicious patients, after diagnosis, according to the patient's etiology, the treatment plan should be determined as soon as possible, such as lymphoma-related patients treated with hormones combined with etoposide, which can greatly improve the prognosis of patients | Drug | Screening patients with suspected hemophagocytic syndrome |
Primary outcome
The suspected patient was diagnosed with hemophagocytic syndrome after complete NK cell activity, triglyceride tests, etc.
Time frame: Time forecasting:2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- 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.
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 Syndrome, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Sang, Doctor (13645207648, sw1981726@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The suspected patient was diagnosed with hemophagocytic syndrome after complete NK cell activity, triglyceride tests, etc. (time frame: Time forecasting:2 years). 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 1 Oct 2024.