HealthyNKTNCT06450743
Age-matched Reference Values for Circulating Natural Killer T-like Cells
A study testing Lymphocyte Immunophenotyping Test in people with Healthy, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lymphocyte Immunophenotyping Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 3 May 2024to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy blood donor
- without acute or chronic pathological conditions
- matched for sex and age with the retrospective adult derivation cohort
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Lymphocyte Immunophenotyping Test
- Keywords
- Lymphocytes, NKT-like cells, Reference Values
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphocyte Immunophenotyping TestDiagnostic test
Absolute enumeration of peripheral blood lymphocyte subpopulations
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Lymphocyte Immunophenotyping Test |
| Validation Cohort | Other | Healthy adult blood donors in order to validate the obtained results. Receives: Diagnostic Test: Lymphocyte Immunophenotyping Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start3 May 2024
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Trombetta, BSc, Principal investigator, Flow Cytometry Laboratory, Clinical Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450743
- Sponsor's protocol ID
- 0014476
- Acronym
- NKT
- Status last verified
- May 2024
- First submitted
- 5 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-matched Reference Values for Circulating Natural Killer t (NKT)-Like Cells
- ClinicalTrials.gov ID
- NCT06450743
- Acronym / sponsor ID
- NKT / 0014476
- Conditions
- Healthy
- Keywords
- Lymphocytes, NKT-like cells, Reference Values
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation Cohort | Other | Diagnostic Test: Lymphocyte Immunophenotyping TestAdult 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). |
| Validation Cohort | Other | Diagnostic Test: Lymphocyte Immunophenotyping TestHealthy adult blood donors in order to validate the obtained results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy blood donor
- without acute or chronic pathological conditions
- matched for sex and age with the retrospective adult derivation cohort
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphocyte Immunophenotyping TestAbsolute enumeration of peripheral blood lymphocyte subpopulations | Diagnostic test | Derivation Cohort, Validation Cohort |
Primary outcome
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.
1 secondary outcome
NKT-like cells reference values validation (absolute number and percentage) using healthy blood donors (>16 years)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Trombetta, BSc principal investigator
Flow Cytometry Laboratory, Clinical Pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphocyte Immunophenotyping Test in people with Healthy, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NKT-like cells reference values determination (absolute number and percentage) from the derivation cohort (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024; AzTrials last refreshed its copy on 27 Oct 2026.