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

NCT06450743 | Completed

• 1 other identifier: 0014476
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Lymphocytes; NKT-like cells; Reference Values

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  1 month

Study Arms (2)

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).

Diagnostic Test: Lymphocyte Immunophenotyping Test

Validation Cohort

OTHER

Healthy adult blood donors in order to validate the obtained results.

Diagnostic Test: Lymphocyte Immunophenotyping Test

Interventions

Lymphocyte Immunophenotyping Test DIAGNOSTIC_TEST

Absolute enumeration of peripheral blood lymphocyte subpopulations

Derivation Cohort; Validation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Location

Study Officials

• Elena Trombetta, BSc

  Flow Cytometry Laboratory, Clinical Pathology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 10, 2024
• Study Start: May 3, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)