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Multicenter clinical trial of low-depth genome sequencing to detect copy number variation to assess prognosis in patients with AML

Multicenter clinical trial of low-depth genome sequencing to detect copy number variation to assess prognosis in patients with AML

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077695
Enrollment
Unknown
Registered
2023-11-16
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia (AML)

Interventions

case series:None

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Newly diagnosed AML patients WHO meet the WHO 2022 diagnostic criteria (except APL) (2) Age =18 years old, gender unlimited (3) Obtain the results of second-generation sequencing gene mutation detection. Including but not limited to FLT3-ITD, NPM1, CEBPA, TP53, RUNX1, ASXL1, BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1, ZRSR2, IDH1, IDH2, DNMT3a, C-kit (4) Obtain fusion gene test results, including but not limited to PML-RARa, RUNX1-RUNX1T1, CBFß-MYH11, MLLT3-KMT2A, MLL rearrangement, BCR-ABL1, DEK-NUP214, MECOM(EVI1) rearrangement (5) Physical strength score 0-3 (WHO standard) (6) Normal liver and kidney function: blood bilirubin =35µmol/L, AST/ALT less than 2 times the upper limit of normal value, blood creatinine =150µmol/L (7) Normal heart function

Exclusion criteria

Exclusion criteria: (1) Non-newly diagnosed AML patients (2) <18 years old (3) Second generation sequencing gene mutation detection and fusion gene detection were not performed at the first diagnosis (4) Patients undergoing allogeneic hematopoietic stem cell transplantation (5) Identify patients with central nervous system invasion (6) Women who are pregnant, planning to become pregnant or breastfeeding (7) Patients with other malignant tumors requiring treatment (8) Active TB patients and HIV-positive patients (9) Drug addiction or mental illness (10) Liver and kidney function was significantly abnormal, exceeding the inclusion criteria (11) Serious heart disease, including myocardial infarction and cardiac insufficiency (12) ECG results: QT interval greater than 450 ms (13) The sample quality is not qualified

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Event-free lifetime;

Countries

China

Contacts

Public ContactSong Yongping

The First Affiliated Hospital of Zhengzhou University

songyongping001@126.com+86 138 0384 6526

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026