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Clinical Application of Novel Panels for Early Precision Diagnosis and Relapse Prediction in High-risk Leukemia

Early Precision Diagnosis and Relapse Prediction Technology Development in High-risk Acute Leukemia and Clinical Application

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03297476
Enrollment
100
Registered
2017-09-29
Start date
2017-12-01
Completion date
2020-12-31
Last updated
2022-03-24

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

Conditions

Leukemia, Acute

Brief summary

Based on the investigator's previous data on risk classification for acute leukemia,the investigators will design a set of panels to detect the gene expression and genomic variants (SNPs, mutation, insertion, deletion and fusion genes, etc), and identify the high-risk subtypes of acute leukemia, such as Ph-like acute lymphoblastic leukemia. Furthermore, the target therapy (Tyrosine Kinase Inhibitors,et.al) will be used to treat the identified patients. In addition, more sensitive minimal residual disease (MRD) detection technology will be designed and used to detect the MRD in patients to early predict the disease relapse.

Detailed description

patient eligibility criteria: newly diagnosed acute leukemia patients with clinical high-risk markers, reflactory and relapsed patients.

Interventions

DIAGNOSTIC_TESTHigh-risk subtype detection panels

The designed detection technology were used to identify the high-risk patients cohort.

Sponsors

Zhongda Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment

Exclusion criteria

* chronic leukemia

Design outcomes

Primary

MeasureTime frameDescription
complete remissionFrom date of randomization or initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsPatients achieve complete remission after initial treatment
relapseFrom date of randomization or complete remission until the date of first documented relapse from any cause, whichever came first, assessed up to 100 weeksPatients' disease progress after complete remission

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026