- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
개입 / 치료
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Monika Holubová, MD, Ph.D.
- 전화번호: +420 377 103 991
- 이메일: holubovam@fnplzen.cz
연구 연락처 백업
- 이름: Lenka Lukášová, MD, Ph.D.
- 전화번호: +420 377 103 871
- 이메일: LUKASOVALE@fnplzen.cz
연구 장소
-
-
Czechia
-
Pilsen, Czechia, 체코, 32300
- University Hospital Pilsen
-
연락하다:
- Monika Holubová, MD, Ph.D.
- 전화번호: +420 377 103 991
- 이메일: holubovam@fnplzen.cz
-
연락하다:
- Lenka Lukášová, MD, Ph.D.
- 전화번호: +420 377 103 871
- 이메일: LUKASOVALE@fnplzen.cz
-
수석 연구원:
- Michal Karas, MD, Ph.D.
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
HSCT patients
Patients who have undergone allogeneic hematopoietic cell transplantation and have been diagnosed with acute myeloid leukemia.
|
Blood draw for diagnostic test
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Detection of peripheral blood iNKTs after HSCT using flow cytometry
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Absolute Number of Circulating iNKT Cells and Their Dynamics After HSCT
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Correlation of iNKT cell levels with Post-transplant Complications
기간: Day 30, day 60, day 90
|
Correlation of iNKT cell levels with Post-transplant Complications
|
Day 30, day 60, day 90
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- QiNKT-HSCT
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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