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Clinical Trials in China / NCT06704542
Starting soon Observational

Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation

NCT06704542 · tracked via the Priya Life Science China tracker
Sponsor
Ruijin Hospital
Phase
Observational
Started
2024-11
Last updated
2024-11-26

Condition(s) studied

ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONDiabetes MellitusImpaired Fasting Glucose

Study summary

To investigate the impact of abnormal glucose tolerance in hematopoietic stem cell transplantation donors on patients' post-transplant survival outcomes.

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
Inclusion Criteria: * 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; Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Tongji Hospital of Huazhong University of Science and Technology, Wuhan Wuhan Hubei
Li Quan Hospital Shanghai Shanghai Municipality
Ruijin Hospital of Shanghai Jiaotong University Shanghai Shanghai Municipality
The First Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
Hospital of Hematology of the Chinese Academy of Medical Sciences Tianjin China

More Ruijin Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06704542 on ClinicalTrials.gov ↗ ← All trials in China