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| ID | Type | Description | Link |
|---|---|---|---|
| PA16-0129 | Other Identifier | MD Anderson Cancer Center |
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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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This observational study is designed to determine the levels of pro-inflammatory markers in patients diagnosed with M-HLH, and to assess whether the cytokine profiles bear an IFNγ signature.
This is a observational study designed to determine the levels of inflammatory markers in patients diagnosed with M-HLH and to assess the relationship between the biomarkers and disease activity in these patients during the M-HLH course. Inflammatory markers will also be measured in a group of control patients diagnosed with hematological malignancy but without HLH. Inflammatory markers include IFNγ and IFNγ-induced chemokines CXCL9 and CXCL10.
In addition to the blood samples for the biomarker analysis, relevant information gathered by the treating physician will be collected in a data collection form. Whenever possible, collection of serum samples for biomarker analysis and relevant information should occur at M-HLH diagnosis, at regular time intervals during the treatment course as well as at resolution or reactivation of the disease.
Blood samples will also be sent to the study sponsor (NovImmune S.A.) for cytokine testing. Before participant's samples are sent to the sponsor for testing, participant's name and any personal identifying information will be coded to protect participant's privacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Malignancy-Associated Hemophagocytic Lymphohistiocytosis | Patients diagnosed with HLH in the context of a malignancy. The diagnosis of M-HLH was established by the treating physician. |
| |
| Absence of HLH in patients diagnosed with malignancy | Patients with a diagnosis of hematological malignancy and never diagnosed with HLH or no suspicion of HLH (at any time, including time after sample collection in case of use of retrospective sample). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draws | Other |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Inflammatory Biomarker - Neopterin |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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Male and female (adult and children) patients who are diagnosed with M-HLH and that meet the inclusion criteria. In addition, patients with a diagnosis of hematological malignancy in the absence of HLH will be included as a control group.
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| Name | Affiliation | Role |
|---|---|---|
| Naval Daver, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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A total of 40 patients were enrolled in the study. Of which 39 patients had a confirmed malignancy and were included in the malignancy set for analysis.
This Phase 4 observational study was conducted in patients diagnosed with malignancy-associated hemophagocytic lymphohistiocytosis (M-HLH) at a single center in the United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hemophagocytic Lymphohistiocytosis (HLH) Patients | All patients diagnosed with HLH in the context of a malignancy. |
| FG001 | Non-HLH Patients | All patients with a diagnosis of hematological malignancy and never diagnosed with HLH or no suspicion of HLH (at any time, including time after sample collection in case of use of retrospective sample). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The malignancy set included all patients who were diagnosed with malignancy.
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| ID | Title | Description |
|---|---|---|
| BG000 | HLH Patients | All patients diagnosed with HLH in the context of a malignancy. |
| BG001 | Non-HLH Patients | All patients with a diagnosis of hematological malignancy and never diagnosed with HLH or no suspicion of HLH (at any time, including time after sample collection in case of use of retrospective sample). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | picogram/milliliter (pg/mL) | From Day 1 up to 39.5 months |
|
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Safety analysis including all-cause mortality, serious adverse events and other (non-serious) adverse events were not monitored as this is an observational study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HLH Patients | All patients diagnosed with HLH in the context of a malignancy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Swedish Orphan Biovitrum | +4686972000 | clinical@sobi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2021 | Apr 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2021 | Apr 2, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D051359 | Lymphohistiocytosis, Hemophagocytic |
| ID | Term |
|---|---|
| D015616 | Histiocytosis, Non-Langerhans-Cell |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Approximate volume of 500 µl - 1 ml of serum or plasma required per time point. Minimum of 1 ml of whole blood collected for genetic characterization.
| Data Collection |
| Other |
|
Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin. |
| From Day 1 up to 39.5 months |
| Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Hemoglobin | Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Hematocrit | Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Erythrocytes | Blood samples was collected at various times after HLH diagnosis to determine the concentration of erythrocytes. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Leukocytes | Blood samples was collected at various times after HLH diagnosis to determine the concentration of leukocytes. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Neutrophils | Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Lymphocytes | Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Monocytes | Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Eosinophils | Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Basophils | Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Platelets | Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets. | From Day 1 up to 39.5 months |
| Mean Plasma Concentration of Fibrinogen | Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen. | From Day 1 up to 39.5 months |
| Mean Plasma Concentration of D-Dimer | Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Ferritin | Blood samples was collected at various times after HLH diagnosis to determine the concentration of ferritin. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Fasting Triglycerides | Blood samples was collected at various times after HLH diagnosis to determine the concentration of fasting triglycerides. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Creatinine | Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine. | From Day 1 up to 39.5 months |
| Mean Plasma Concentration of Blood Urea Nitrogen | Blood samples was collected at various times after HLH diagnosis to determine the concentration of blood urea nitrogen. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Albumin | Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Sodium | Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Beta2-Microglobulin | Blood samples was collected at various times after HLH diagnosis to determine the concentration of beta2-microglobulin. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Immunoglobulin G (IgG) | Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of C-Reactive Protein | Blood samples was collected at various times after HLH diagnosis to determine the concentration of c-reactive protein. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Aspartate Aminotransferase | Blood samples was collected at various times after HLH diagnosis to determine the concentration of aspartate aminotransferase. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Alanine Aminotransferase | Blood samples was collected at various times after HLH diagnosis to determine the concentration of alanine aminotransferase. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Alkaline Phosphatase | Blood samples was collected at various times after HLH diagnosis to determine the concentration of alkaline phosphatase. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Lactate Dehydrogenase | Blood samples was collected at various times after HLH diagnosis to determine the concentration of lactate dehydrogenase. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Total Bilirubin | Blood samples was collected at various times after HLH diagnosis to determine the concentration of total bilirubin. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Conjugated Bilirubin | Blood samples was collected at various times after HLH diagnosis to determine the concentration of conjugated bilirubin. | From Day 1 up to 39.5 months |
| Mean Serum Concentration of Natural Killer (NK) Cell Activity | Blood samples was collected at various times after HLH diagnosis to determine the concentration of NK cell activity. A lytic unit 30 (LU30) was defined as the number of effector cells necessary to cause lysis of 30% of its target cells. | From Day 1 up to 39.5 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9. | The malignancy set included all patients who were diagnosed with malignancy. | Posted | Mean | Standard Deviation | pg/mL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg. | The malignancy set included all patients who were diagnosed with malignancy. | Posted | Mean | Standard Deviation | pg/mL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10. | The malignancy set included all patients who were diagnosed with malignancy. | Posted | Mean | Standard Deviation | pg/mL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | pg/mL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6. | The malignancy set included all patients who were diagnosed with malignancy. | Posted | Mean | Standard Deviation | pg/mL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Inflammatory Biomarker - Neopterin | Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | nanomoles | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa. | The malignancy set included all patients who were diagnosed with malignancy. | Posted | Mean | Standard Deviation | pg/mL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg. | The malignancy set included all patients who were diagnosed with malignancy. | Posted | Mean | Standard Deviation | pg/mL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163. | The malignancy set included all patients who were diagnosed with malignancy. | Posted | Mean | Standard Deviation | nanogram/mL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra) | Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra. | The malignancy set included all patients who were diagnosed with malignancy. | Posted | Mean | Standard Deviation | pg/mL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Hemoglobin | Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | gram/deciliter (g/dL) | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Hematocrit | Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | liter (L) of cells/L of blood | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Erythrocytes | Blood samples was collected at various times after HLH diagnosis to determine the concentration of erythrocytes. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | cells*10^12/L | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Leukocytes | Blood samples was collected at various times after HLH diagnosis to determine the concentration of leukocytes. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | cells*10^9/L | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Neutrophils | Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | cells*10^3/microliter (mcL) | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Lymphocytes | Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | cells*10^3/mcL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Monocytes | Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | cells*10^3/mcL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Eosinophils | Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | cells*10^3/mcL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Basophils | Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | cells*10^3/mcL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Platelets | Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | cells*10^3/mcL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Plasma Concentration of Fibrinogen | Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | milligram (mg)/dL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Plasma Concentration of D-Dimer | Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | microgram (mcg)/mL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Ferritin | Blood samples was collected at various times after HLH diagnosis to determine the concentration of ferritin. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | mcg/L | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Fasting Triglycerides | Blood samples was collected at various times after HLH diagnosis to determine the concentration of fasting triglycerides. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | mg/dL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Creatinine | Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | mg/dL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Plasma Concentration of Blood Urea Nitrogen | Blood samples was collected at various times after HLH diagnosis to determine the concentration of blood urea nitrogen. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | mg/dL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Albumin | Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | g/dL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Sodium | Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | millimoles/L | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Beta2-Microglobulin | Blood samples was collected at various times after HLH diagnosis to determine the concentration of beta2-microglobulin. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | mg/L | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Immunoglobulin G (IgG) | Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | mg/dL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of C-Reactive Protein | Blood samples was collected at various times after HLH diagnosis to determine the concentration of c-reactive protein. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | mg/dL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Aspartate Aminotransferase | Blood samples was collected at various times after HLH diagnosis to determine the concentration of aspartate aminotransferase. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | international units/L (IU/L) | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Alanine Aminotransferase | Blood samples was collected at various times after HLH diagnosis to determine the concentration of alanine aminotransferase. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | IU/L | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Alkaline Phosphatase | Blood samples was collected at various times after HLH diagnosis to determine the concentration of alkaline phosphatase. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | IU/L | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Lactate Dehydrogenase | Blood samples was collected at various times after HLH diagnosis to determine the concentration of lactate dehydrogenase. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | IU/L | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Total Bilirubin | Blood samples was collected at various times after HLH diagnosis to determine the concentration of total bilirubin. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | mg/dL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Conjugated Bilirubin | Blood samples was collected at various times after HLH diagnosis to determine the concentration of conjugated bilirubin. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | mg/dL | From Day 1 up to 39.5 months |
|
|
|
| Primary | Mean Serum Concentration of Natural Killer (NK) Cell Activity | Blood samples was collected at various times after HLH diagnosis to determine the concentration of NK cell activity. A lytic unit 30 (LU30) was defined as the number of effector cells necessary to cause lysis of 30% of its target cells. | The malignancy set included all patients who were diagnosed with malignancy. Only patients with data available are reported. | Posted | Mean | Standard Deviation | LU30 | From Day 1 up to 39.5 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Non-HLH Patients | All patients with a diagnosis of hematological malignancy and never diagnosed with HLH or no suspicion of HLH (at any time, including time after sample collection in case of use of retrospective sample). | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |