Age-matched Reference Values for Circulating Natural Killer T-like Cells

Age-matched Reference Values for Circulating Natural Killer t (NKT)-Like Cells

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06450743

Acronym

NKT

Enrollment

Registered

2024-06-10

Start date

2024-05-03

Completion date

2024-05-31

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Lymphocytes, NKT-like cells, Reference Values

Brief summary

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.

Interventions

DIAGNOSTIC_TESTLymphocyte Immunophenotyping Test

Absolute enumeration of peripheral blood lymphocyte subpopulations

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy blood donor * without acute or chronic pathological conditions * matched for sex and age with the retrospective adult derivation cohort

Exclusion criteria

* a history of immunological or hematological diseases, immunosuppressive or immunostimulant therapies, or ongoing infections * one of the lymphocyte subpopulations tested out of range * undergoing surgery or dentistry intervention in the past two months

Design outcomes

Primary

Measure	Time frame	Description
NKT-like cells reference values determination (absolute number and percentage) from the derivation cohort	2 months	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.

Secondary

Measure	Time frame	Description
NKT-like cells reference values validation (absolute number and percentage) using healthy blood donors (>16 years)	1 month	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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026