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

NCT ID: NCT06450743

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-03

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Derivation Cohort

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).

Group Type OTHER

Lymphocyte Immunophenotyping Test

Intervention Type DIAGNOSTIC_TEST

Absolute enumeration of peripheral blood lymphocyte subpopulations

Validation Cohort

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

Group Type OTHER

Lymphocyte Immunophenotyping Test

Intervention Type DIAGNOSTIC_TEST

Absolute enumeration of peripheral blood lymphocyte subpopulations

Interventions

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Lymphocyte Immunophenotyping Test

Absolute enumeration of peripheral blood lymphocyte subpopulations

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Trombetta, BSc

Role: PRINCIPAL_INVESTIGATOR

Flow Cytometry Laboratory, Clinical Pathology

Locations

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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, Italy

Site Status

Countries

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Italy

Other Identifiers

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0014476

Identifier Type: -

Identifier Source: org_study_id

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