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

Sponsor
Zhongda Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03297476
Collaborator
(none)
100
1
37
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Early Precision Diagnosis and Relapse Prediction Technology Development in High-risk Acute Leukemia and Clinical Application
Actual Study Start Date :
Dec 1, 2017
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. complete remission [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

  2. relapse [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment
Exclusion Criteria:
  • chronic leukemia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University Nanjing Jiangsu China 210009

Sponsors and Collaborators

  • Zhongda Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ge Zheng, Director of Hematology Department, Zhongda Hospital
ClinicalTrials.gov Identifier:
NCT03297476
Other Study ID Numbers:
  • ZDYYGZ201708
First Posted:
Sep 29, 2017
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022