Asia Myelodysplastic Syndrome (MDS) Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Participant myelodysplastic syndromes diagnosis information
研究概览
简要总结
The purpose of this study is to provide a contemporary view and offer invaluable insights into the demographic profiles, clinical characteristics, treatments, and real-world outcomes of individuals with myelodysplastic syndromes (MDS) in Asia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retrospective enrolment of Myelodysplastic Syndrome (MDS) participants:
- •Aged at least 18 years at initial diagnosis of MDS
- •Diagnosed with MDS according to World Health Organization (WHO) 2008, WHO 2016, or WHO 2022 criteria between 1 January 2019 and 31 December 2022; and
- •Diagnosed with MDS within 100 days from the date of diagnostic bone marrow (BM) aspirate
- •Inclusion criteria for the prospective enrolment of MDS participants:
- •Aged at least 18 years at initial diagnosis of MDS; and
- •Diagnosed with MDS according to World Health Organization (WHO) 2008, WHO 2016, or WHO 2022 criteria between 1 October 2025 and 30 September 2026; and
- •Diagnosed with MDS within 100 days from the date of diagnostic BM aspirate
排除标准
- 未提供
研究组 & 干预措施
Group 1
Participants diagnosed with myelodysplastic syndromes (MDS)
干预措施: Prescribed treatments for myelodysplastic syndromes (MDS) (Drug)
结局指标
主要结局
Participant myelodysplastic syndromes diagnosis information
时间窗: Baseline
Participant Eastern Cooperative Oncology Group (ECOG) Performance status at diagnosis
时间窗: Baseline
Participant comorbidities at diagnosis
时间窗: Baseline
Participant Charlson comorbidity index (CCI) score at diagnosis
时间窗: Baseline
Prior clinical diagnosis of other cancers
时间窗: Baseline
Prior clinical diagnosis of hematological diseases
时间窗: Baseline
Anemia status at diagnosis
时间窗: Bseline
Thrombocytopenia status at diagnosis
时间窗: Baseline
Neutropenia status at diagnosis
时间窗: Baseline
Iron overload status at diagnosis
时间窗: Baseline
Red blood cell (RBC) transfusion dependence status at diagnosis
时间窗: Baseline
International Prognostic Scoring System (IPSS) score at diagnosis
时间窗: Baseline
Revised International Prognostic Scoring System (IPSS-R) score at diagnosis
时间窗: Baseline
Participant age
时间窗: Baseline
Participant sex
时间窗: Baseline
Participant race
时间窗: Baseline
Participant weight
时间窗: Baseline
Participant height
时间窗: Baseline
Participant body mass index (BMI)
时间窗: Baseline
Participant smoking status
时间窗: Baseline
Participant drinking status
时间窗: Baseline
Family history of MDS or other hematopoietic cancers
时间窗: Baseline
Molecular International Prognostic Scoring System (IPSS-M) score at diagnosis
时间窗: Baseline
Bone marrow aspirate results
时间窗: Baseline and up to 2-years
Presence of dysplasia
时间窗: Baseline and up to 2-years
Cytogenetic test results
时间窗: Baseline and up to 2-years
Mutation test results at diagnosis
时间窗: Baseline
Complete blood count test results at diagnosis
时间窗: Baseline
Mean corpuscular volume (MCV)
时间窗: Baseline and up to 2-years
C-reactive protein (CRP)
时间窗: Baseline and up to 2-years
Serum ferritin (SF) level
时间窗: Baseline and up to 2-years
Serum erythropoietin levels
时间窗: Baseline and up to 2-years
Lactate dehydrogenase (LDH)
时间窗: Baseline and up to 2-years
次要结局
- Duration of response (DOR)(Baseline and up to 2-years)
- Real-world relapse-free survival (rwRFS)(Baseline and up to 2-years)
- Initial treatment received following diagnosis(Baseline)
- Prior treatments and concomitant medications received(Baseline)
- Subsequent treatments received(Up to 2-years)
- Time from diagnosis to treatment initiation(Baseline)
- Treatment duration(Up to 2-years)
- Real-world overall survival (rwOS)(Baseline and up to 2-years)
- Time to disease-risk progression (per IPSS-R)(Baseline and up to 2-years)
- Time to acute myeloid leukemia (AML) progression(Baseline and up to 2-years)
- Time to iron overload(Baseline and up to 2-years)
- Overall response rate (ORR)(Baseline and up to 2-years)