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NCT06450743 Clinical Trial

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

Healthy Clinical Trial

— NKT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06450743
Other study ID # 0014476
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2024
Est. completion date May 31, 2024

Study information
Verified date May 2024
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Lymphocyte Immunophenotyping Test
Absolute enumeration of peripheral blood lymphocyte subpopulations

Locations
Country Name City State
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan MI

Sponsors (1)
Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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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