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NCT05983172 Clinical Trial

Multi-omics Approach of Risk Stratification for Patients With de Novo Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:
Multi-omics Approach of Risk Stratification for Patients With de Novo Acute Myeloid Leukemia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05983172
Other study ID # 202306138RINB
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 2023
Est. completion date July 2026

Study information
Verified date July 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The investigators will use machine learning to identify features on bone marrow smears and select features that are related to gene mutations, gene expression, or prognosis. The investigators will then use genome-wide transcriptomic profiling to investigate gene expression that is associated with patients' outcomes. The investigators will design a next-generation sequencing panel with unique molecular index and assess its feasibility and robustness in detecting measurable residual disease and optimize the panel/platform/bioinformatic pipeline. Finally, The investigators will use machine learning to integrate bone marrow smear features, gene mutations, gene expression, and measurable residual disease to construct a comprehensive risk assessment system that is based on multi-omics data. The investigators believe that such a platform will help physicians to design the most appropriate treatment strategies for individual patients, not only advancing the concept of precision medicine but also improving patients' prognoses.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1500
Est. completion date July 2026
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Diagnosed with acute myeloid leukemia at the National Taiwan University Hospital 2. Ever enrolled in 201802021RINC?202109078RINB?201709072RINC Exclusion Criteria: Nil

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival From date of diagnosis until the date of death from any cause, assessed up to 30 years
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