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OpenTrials
Completed

NCT Number: NCT06450743

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

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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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lymphocyte Immunophenotyping Test

Diagnostic Test

Absolute enumeration of peripheral blood lymphocyte subpopulations

Primary outcomes

  1. NKT-like cells reference values determination (absolute number and percentage) from the derivation cohort

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

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

Acronym: NKT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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