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

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.

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Key information

Conditions

Leukemia, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type

Age range

14 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University

Nanjing, Jiangsu, 210009, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment

Exclusion criteria

chronic leukemia

Treatment and study plan

High-risk subtype detection panels

Diagnostic Test

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

Primary outcomes

complete remission

Time frame: From 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 months

Patients achieve complete remission after initial treatment
relapse

Time frame: From date of randomization or complete remission until the date of first documented relapse from any cause, whichever came first, assessed up to 100 weeks

Patients' disease progress after complete remission

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Sep 29, 2017
Registry last updated: Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed