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Reassessment of Prognosis in TP53-Mutated Acute Myeloid Leukemia: A Retrospective Cohort Study Based on Clonal Position, Suspected Biallelic Inactivation Scoring, Continuous VAF Modeling, and Functional Impact Stratification

Reassessment of Prognosis in TP53-Mutated Acute Myeloid Leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126804
Enrollment
Unknown
Registered
2026-06-16
Start date
2026-06-17
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Acute myeloid leukemia with TP53 mutation

Interventions

Observation group:None

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with AML according to WHO 5th edition or ICC criteria, including de novo AML, secondary AML, or therapy-related AML; 2.Availability of bone marrow or peripheral blood samples suitable for NGS analysis at diagnosis, prior to initial treatment, or at a predefined baseline time point; 3.Detection of at least one TP53 mutation that can be definitively classified following basic quality control; 4.Availability of traceable clinical baseline data and follow-up outcomes; 5.For analyses of CR, complete data sufficient to assess treatment response must be available.

Exclusion criteria

Exclusion criteria: 1.Lack of a confirmable baseline sample; 2.Sequencing quality insufficient to determine TP53 status; 3.Missing key outcome information.

Design outcomes

Primary

MeasureTime frame
Complete remission;Overall survival;Variant allele frequency;Model differentiation;AUC;Brier score ;

Secondary

MeasureTime frame
Bone marrow blast percentage;Hemoglobin;Absolute neutrophil count;Mutation type;Exon / mutation location;Co-mutation;Platelet count;

Countries

China

Contacts

Public ContactSongfu Jiang

The First Affiliated Hospital of Wenzhou Medical University

Songfu.Jiang@wzhospital.cn+86 577 5557 8027

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026