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

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.

Study Overview

• Status: Completed
• Conditions: Leukemia, Acute
• Intervention / Treatment: Diagnostic test: High-risk subtype detection panels

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with acute leukemia (newly diagnosis)

Description

Inclusion Criteria:

• Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment

Exclusion Criteria:

• chronic leukemia

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
high-risk group; Selected by "High-risk subtype detection panels"	Diagnostic test: High-risk subtype detection panels; The designed detection technology were used to identify the high-risk patients cohort.
non high-risk group; Selected by "High-risk subtype detection panels"	Diagnostic test: High-risk subtype detection panels; The designed detection technology were used to identify the high-risk patients cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete remission	Patients achieve complete remission after initial treatment	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
relapse	Patients' disease progress after complete remission	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

Collaborators and Investigators

• Sponsor: Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: ZDYYGZ201708

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No