Beta
Trial Radar KI
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

Noch nicht rekrutierend
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 Glucose
Weitere 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/StudienarmIntervention/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
ErgebnismessungBeschreibung der MessungZeitrahmen
Overall Survival (OS)
Patient's overall survival time since hematopoietic stem cell transplantation
One year-overall survival since hematopoietic stem cell transplantation
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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:

    1. Aspartate aminotransferase (AST) ≤ 3-fold (upper limit of norma, ULN);
    2. Alanine aminotransferase (ALT) ≤ 3x ULN;
    3. 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;
    4. Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min;
    5. 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 Hospital logoRuijin Hospital
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]