NCT05983172

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Aug 2023Jul 2026

First Submitted

Initial submission to the registry

July 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

August 14, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

July 30, 2023

Last Update Submit

August 9, 2023

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemiaMachine learningArtificial intelligenceRisk stratification

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    From date of diagnosis until the date of death from any cause, assessed up to 30 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with acute myeloid leukemia

You may qualify if:

  • Diagnosed with acute myeloid leukemia at the National Taiwan University Hospital
  • Ever enrolled in 201802021RINC、202109078RINB、201709072RINC

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Xavier Cheng-Hong Tsai, MD, MSc, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and attending physician

Study Record Dates

First Submitted

July 30, 2023

First Posted

August 9, 2023

Study Start

August 1, 2023

Primary Completion

July 1, 2024

Study Completion (Estimated)

July 1, 2026

Last Updated

August 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)