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

June 10, 2024 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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).
Diagnostic test: Lymphocyte Immunophenotyping Test
Absolute enumeration of peripheral blood lymphocyte subpopulations
Other: Validation Cohort
Healthy adult blood donors in order to validate the obtained results.
Diagnostic test: Lymphocyte Immunophenotyping Test
Absolute enumeration of peripheral blood lymphocyte subpopulations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Principal Investigator: Elena Trombetta, BSc, Flow Cytometry Laboratory, Clinical Pathology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2024

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0014476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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