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Few data are so far available regarding the adult normal values of circulating NKT-like cell concentration, and none for the pediatric population. The primary objective of this study is to determine the reference values for NKT-like cells in pediatric and adult patients (derivation cohort). The secondary objective is to validate the results obtained from the adult derivation cohort with those obtained from an adult validation cohort, consisting of a group of healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Derivation Cohort | Other | Adult and pediatric patients who have routinely performed the lymphocyte immunophenotyping test, including also the enumeration of NKT-like cells, to exclude an immunological impairment during the period from May 2019 to March 2020 (for adults) and from May 2019 to August 2021 (for pediatric patients). |
|
| Validation Cohort | Other | Healthy adult blood donors in order to validate the obtained results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymphocyte Immunophenotyping Test | Diagnostic Test | Absolute enumeration of peripheral blood lymphocyte subpopulations |
|
| Measure | Description | Time Frame |
|---|---|---|
| NKT-like cells reference values determination (absolute number and percentage) from the derivation cohort | Retrospective analysis of NKT-like cell counts from the lymphocyte immunophenotyping test performed on adult (>16 years) and pediatric outpatients divided in narrow age ranges (0-15 months, 15-24 months, 2-5 years, 5-10 years, 10-16 years) to obtain reference values. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| NKT-like cells reference values validation (absolute number and percentage) using healthy blood donors (>16 years) | Analysis of NKT-like cell counts from the lymphocyte immunophenotyping test on healthy adult blood donors and comparison with those obtained from adult patients of derivation cohort to verify that will not statistically differ. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Trombetta, BSc | Flow Cytometry Laboratory, Clinical Pathology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | MI | 20122 | Italy |
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