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Die klinische Studie NCT06704542 für Allogene hämatopoetische Stammzelltransplantation, Diabetes mellitus, Impaired Fasting Glucose ist noch nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation 1.000
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06704542 ist eine beobachtungsstudie zur Untersuchung von Allogene hämatopoetische Stammzelltransplantation, Diabetes mellitus, Impaired Fasting Glucose und hat den Status noch nicht rekrutierend. Der Start ist für 1. November 2024 geplant, bis 1.000 Teilnehmer aufgenommen werden. Durchgeführt von Ruijin Hospital wird der Abschluss für 1. April 2025 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 26. November 2024 aktualisiert.
Kurzbeschreibung
To investigate the impact of abnormal glucose tolerance in hematopoietic stem cell transplantation donors on patients' post-transplant survival outcomes.
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller 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
Erkrankungen
Allogene hämatopoetische StammzelltransplantationDiabetes mellitusImpaired Fasting GlucoseWeitere Studien-IDs
- RJBMT-07
NCT-Nummer
Studienbeginn (tatsächlich)
2024-11
Zuletzt aktualisiert
2024-11-26
Studienende (vorauss.)
2025-04
Geplante Rekrutierung
1.000
Studientyp
Beobachtungsstudie
Status
Noch nicht rekrutierend
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
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% | Nicht zutreffend |
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) | Nicht zutreffend |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Overall Survival (OS) | Patient's overall survival time since hematopoietic stem cell transplantation | One year-overall survival since hematopoietic stem cell transplantation |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Zugelassene Geschlechter
Alle
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
Verantwortliche Partei
Hu Xiaoxia, Hauptprüfer, Director of the Center for Translational Medicine, Ruijin Hospital
Zentrale Studienkontakte
Kontakt: Xiaoxia Hu, (86) 13795437259, [email protected]
6 Studienstandorte in 1 Ländern
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Weijie Cao, Kontakt, [email protected]
Hubei
Tongji Hospital of Huazhong University of Science and Technology, Wuhan, Wuhan, Hubei, China
Yang Cao, Kontakt, [email protected]
Shanghai Municipality
Li Quan Hospital, Shanghai, Shanghai Municipality, China
Chun Wang, Kontakt, [email protected]
Ruijin Hospital of Shanghai Jiaotong University, Shanghai, Shanghai Municipality, China
Xiaoxia Hu, Doctor, Kontakt, (86) 021-64370045, [email protected]
Zhejiang
The First Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Yanmin Zhao, Kontakt, [email protected]
Hospital of Hematology of the Chinese Academy of Medical Sciences, Tianjin, China
Yawei Zheng, Kontakt, [email protected]