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De klinische studie NCT06704542 voor Allogene hematopoëtische stamceltransplantatie, Diabetes mellitus, Impaired Fasting Glucose is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation 1.000
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De klinische studie NCT06704542 is een observationeel studie bij Allogene hematopoëtische stamceltransplantatie, Diabetes mellitus, Impaired Fasting Glucose met de status nog niet rekruterend. De inclusie van 1.000 deelnemers start op 1 november 2024. De studie wordt geleid door Ruijin Hospital en de voltooiing is gepland op 1 april 2025. Laatste update op ClinicalTrials.gov: 26 november 2024.
Beknopte samenvatting
To investigate the impact of abnormal glucose tolerance in hematopoietic stem cell transplantation donors on patients' post-transplant survival outcomes.
Uitgebreide beschrijving
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an important means of treating a variety of hematologic disorders. With the progress of HSCT technology, especially the research on haploidentical transplantation (HID-HSCT), the range of donor choices for hematological patients has been expanded, and theoretically, the era of "everyone has a donor" has been reached, which has increased the chances for...Toon meer
Officiële titel
A Study of the Impact of Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation Donors on Recipients' Post-Transplant Survival Outcomes: A Multicenter Retrospective Cohort Study Based on HIS Data
Aandoeningen
Allogene hematopoëtische stamceltransplantatieDiabetes mellitusImpaired Fasting GlucoseAndere studie-ID's
- RJBMT-07
NCT-ID
Startdatum (Werkelijk)
2024-11
Laatste update geplaatst
2024-11-26
Verwachte einddatum
2025-04
Inschrijving (Geschat)
1.000
Studietype
Observationeel
Status
Nog niet rekruterend
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Case Group patients who underwent allogeneic hematopoietic stem cell transplantation from March 2019 to March 2024; donor fasting blood glucose and/or HbA1c data available; fasting blood glucose ≥6.1 mmol/L or HbA1c ≥5.7% | N.v.t. |
Control Group patients who underwent allogeneic hematopoietic stem cell transplantation from March 2019 to March 2024; donor fasting blood glucose and/or HbA1c data available; fasting blood glucose \<6.1 mmol/L; HbA1c \<5.7% (if available) | N.v.t. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Overall Survival (OS) | Patient's overall survival time since hematopoietic stem cell transplantation | One year-overall survival since hematopoietic stem cell transplantation |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Non-relapse Mortality (NRM) | NRM after hematopoietic stem cell transplantation | One year since hematopoietic stem cell transplantation |
Relapse-free Survival (RFS) | RFS after hematopoietic stem cell transplantation | One year since hematopoietic stem cell transplantation |
Event-free Survival (EFS) | EFS after hematopoietic stem cell transplantation | One year since hematopoietic stem cell transplantation |
Graft versus Host Disease (GvHD) incidence | GvHD incidence after hematopoietic stem cell transplantation | One year since hematopoietic stem cell transplantation |
GvHD and Relapse-free Survival (GRFS) | GRFS incidence after hematopoietic stem cell transplantation | One year since hematopoietic stem cell transplantation |
Cumulative Incidence Rate (CIR) | CIR after hematopoietic stem cell transplantation | One year since hematopoietic stem cell transplantation |
Graft Time of Different Cell Subpopulation | Graft Time of Platelet, Neutrophil | One year since hematopoietic stem cell transplantation |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind, Volwassene, Oudere volwassene
Geslachten die in aanmerking komen voor de studie
Allen
Patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) between March 2019 and March 2024;
Donor had fasting blood glucose and/or HbA1c records
Eastern Cooperative Oncology Group (ECOG) physical fitness score of 0-2
Survived at least 12 weeks after HSCT
Voluntarily signed the Informed Consent Form
Had appropriate organ function;
Laboratory results within 7 days prior to HSCT met the following criteria:
- Aspartate aminotransferase (AST) ≤ 3-fold (upper limit of norma, ULN);
- Alanine aminotransferase (ALT) ≤ 3x ULN;
- Total serum bilirubin ≤ 1.5 times the upper limit of normal ULN unless the patient has documented Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included;
- Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min;
- Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN;
- Active autoimmune diseases such as SLE, rheumatoid arthritis, etc.
- Active cardiovascular disease such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any Grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) Functional Class, or a history of myocardial infarction in the 6 months prior to screening;
- Other serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes);
- HIV infection, or chronic infection with hepatitis B virus (HBsAg-positive) or hepatitis C virus (anti-HCV-positive) that cannot be controlled by medications;
- Patients with other uncured tumors
- Patients with neurological or psychiatric disorders
- Patients who were unable to understand or comply with the research protocol or are unable to sign the Informed Consent Form
Ruijin HospitalVerantwoordelijke instantie
Hu Xiaoxia, Hoofdonderzoeker, Director of the Center for Translational Medicine, Ruijin Hospital
Centraal Contactpersoon
Contact: Xiaoxia Hu, (86) 13795437259, [email protected]
6 Studielocaties in 1 landen
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Weijie Cao, Contact, [email protected]
Hubei
Tongji Hospital of Huazhong University of Science and Technology, Wuhan, Wuhan, Hubei, China
Yang Cao, Contact, [email protected]
Shanghai Municipality
Li Quan Hospital, Shanghai, Shanghai Municipality, China
Chun Wang, Contact, [email protected]
Ruijin Hospital of Shanghai Jiaotong University, Shanghai, Shanghai Municipality, China
Xiaoxia Hu, Doctor, Contact, (86) 021-64370045, [email protected]
Zhejiang
The First Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Yanmin Zhao, Contact, [email protected]
Hospital of Hematology of the Chinese Academy of Medical Sciences, Tianjin, China
Yawei Zheng, Contact, [email protected]