- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03297476
Clinical Application of Novel Panels for Early Precision Diagnosis and Relapse Prediction in High-risk Leukemia
March 23, 2022 updated by: Ge Zheng, Zhongda Hospital
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
high-risk group
Selected by "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"
|
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
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
|
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
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
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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