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

NCT03297476 | Completed

• 1 other identifier: ZDYYGZ201708
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Acute

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

high-risk group

Selected by "High-risk subtype detection panels"

Diagnostic Test: High-risk subtype detection panels

non high-risk group

Selected by "High-risk subtype detection panels"

Diagnostic Test: High-risk subtype detection panels

Interventions

High-risk subtype detection panels DIAGNOSTIC_TEST

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

high-risk group; non high-risk group

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with acute leukemia (newly diagnosis)

You may qualify if:

• Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment

You may not qualify if:

• chronic leukemia

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210009, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patients' samples from bone marrow

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hematology Department

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: September 29, 2017
• Study Start: December 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

CN (1)