- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07570407
Quantification of Peripheral Blood iNKTs After Allogeneic Stem Cell Transplantation (QiNKT-HSCT)
Standardised Quantification of Invariant NKT Cells Using DryTube Technology and Flow Cytometry in Patients Who Have Undergone Allogeneic Haematopoietic Stem Cell Transplantation.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Allogeneic haematopoietic stem cell transplantation (HSCT) is a treatment for many serious haematological malignancies. Despite advances in pre- and post-transplant management, a significant proportion of patients still develop adverse effects such as graft-versus-host disease (GvHD), relapse or cytomegalovirus reactivation. These reactions can significantly reduce patients' quality of life and may even be fatal. Invariant NKT cells (hereafter referred to as iNKT cells) are a rare population of T lymphocytes that play an important role in regulating the immune response. Depending on the expression of CD4 and CD8 markers, they can be divided into several subpopulations. iNKT cells can simultaneously support both Th1 and Th2 immune responses while suppressing the inflammatory response. Therefore, they appear to be suitable for treating diseases involving deregulated immunity, such as GvHD, autoimmune diseases, and oncological diseases. The concentration of iNKT cells after HSCT is highly variable. According to the available data, iNKT cell kinetics correspond to the severity of GvHD, as well as the risk of relapse and the development of infectious complications. However, these data are usually obtained using locally set protocols and come from single-centre measurements, which reduces their validity and clinical utility as both a biomarker and background data for possible allogeneic applications of iNKT cells in patients with low levels. To eliminate bias caused by specific local data processing and provide a robust dataset, a multicentre study is necessary to yield a representative set of results, as this is the only way to definitively establish the impact of iNKT cell levels on post-transplant outcomes. Flow cytometric analysis enables the combined examination of specific markers on the surface of cells and inside them. Due to the increasing complexity and heterogeneity of protocols, antibody manufacturers often resort to standardised dried panels, which ensure high consistency of measured data.
This project will involve monitoring iNKT cells at defined time points following allogeneic transplantation. The project's outcomes will be to determine the feasibility of standardising iNKT monitoring using the DryTube flow cytometry assay, establish differences in iNKT levels in transplanted patients across different centres, and estimate the association between iNKT levels and post-transplant complications.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Monika Holubová, MSc.
- Telefoonnummer: +420 377 103 991
- E-mail: holubovam@fnplzen.cz
Studie Contact Back-up
- Naam: Lenka Lukášová, MD, MSc.
- Telefoonnummer: +420 377 103 871
- E-mail: LUKASOVALE@fnplzen.cz
Studie Locaties
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Czechia
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Pilsen, Czechia, Tsjechië, 32300
- Werving
- University Hospital Pilsen
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Contact:
- Monika Holubová, MSc.
- Telefoonnummer: +420 377 103 991
- E-mail: holubovam@fnplzen.cz
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Contact:
- Lenka Lukášová, MD, MSc.
- Telefoonnummer: +420 377 103 871
- E-mail: LUKASOVALE@fnplzen.cz
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Hoofdonderzoeker:
- Michal Karas, MD, MSc.
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Diagnosis: AML (exlusion of secondary disease)
- Disease status at time of HSCT: complete remission
- Karnofsky performance status: ≥80%
- Source of HSC: PBSC
Exclusion Criteria:
- Prior transplant
- Uncontrolled Malignancy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
HSCT patients
Patients who have undergone allogeneic hematopoietic cell transplantation and have been diagnosed with acute myeloid leukemia.
|
Blood draw for diagnostic test
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Detection of peripheral blood iNKTs after HSCT using flow cytometry
Tijdsspanne: Day 30, day 60, day 90
|
iNKTs will be monitored in peripheral blood using a mixture of dried antibodies and bulk lysis and flow cytometry.
This mixture of antibodies contains the specific iNKT marker (TCRVα24Jα18) and markers for the main subsets.
The percentage of iNKT cells among leukocytes and T cells, as well as the proportion of CD4 and CD8 iNKT subsets, will be provided.
|
Day 30, day 60, day 90
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Absolute Number of Circulating iNKT Cells and Their Dynamics After HSCT
Tijdsspanne: Day 30, day 60, day 90
|
Leukocyte count will be estimated through hematological analysis, and circulating iNKTs will be counted based on flow cytometry percentage in Patient´s Peripheral Blood At day + 30, +60, +90 After HSCT.
The level of iNKTs will be reported as the number of cells per milliliter of peripheral blood.
|
Day 30, day 60, day 90
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Correlation of iNKT cell levels with Post-transplant Complications
Tijdsspanne: Day 30, day 60, day 90
|
Correlation of iNKT cell levels with Post-transplant Complications
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Day 30, day 60, day 90
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Neoplasmata
- Ziekte attributen
- Neoplasmata per histologisch type
- Hematologische ziekten
- Leukemie, myeloïde
- Leukemie
- Pathologische aandoeningen, tekenen en symptomen
- Hemische en lymfatische ziekten
- Herhaling
- Leukemie, myeloïde, acuut
- Onderzoekstechnieken
- Exemplaarbehandeling
- Klinische laboratoriumtechnieken
- Diagnostische technieken en procedures
- Diagnose
- Buren
- Chirurgische procedures, operatief
- Bloedspecimenverzameling
Andere studie-ID-nummers
- QiNKT-HSCT
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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