Leukemia, AcuteNCT03297476
Clinical Application of Novel Panels for Early Precision Diagnosis and Relapse Prediction in High-risk Leukemia
An observational study of Leukemia, Acute, run by Zhongda Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Leukemia, Acute
- What is being tested?
- High-risk subtype detection panels
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with acute leukemia (newly diagnosis)
Who may be able to join
- Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment
Who cannot join
- chronic leukemia
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University
Nanjing, Jiangsu, 210009
About this study
Official title: 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.
Read the detailed description
patient eligibility criteria: newly diagnosed acute leukemia patients with clinical high-risk markers, reflactory and relapsed patients.
- Conditions
- Leukemia, Acute
- Being tested
- High-risk subtype detection panels
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-risk subtype detection panelsDiagnostic test
The designed detection technology were used to identify the high-risk patients cohort.
| Study group | Role | What they receive |
|---|---|---|
| high-risk group | Selected by "High-risk subtype detection panels" Receives: Diagnostic Test: High-risk subtype detection panels | |
| non high-risk group | Selected by "High-risk subtype detection panels" Receives: Diagnostic Test: High-risk subtype detection panels |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission
Patients achieve complete remission after initial treatment
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Dec 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ge Zheng, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297476
- Sponsor's protocol ID
- ZDYYGZ201708
- Status last verified
- Mar 2022
- First submitted
- 15 Aug 2017
- Last updated
- 24 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Precision Diagnosis and Relapse Prediction Technology Development in High-risk Acute Leukemia and Clinical Application
- ClinicalTrials.gov ID
- NCT03297476
- Acronym / sponsor ID
- ZDYYGZ201708
- Conditions
- Leukemia, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
patient eligibility criteria: newly diagnosed acute leukemia patients with clinical high-risk markers, reflactory and relapsed patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-risk group | – | Diagnostic Test: High-risk subtype detection panelsSelected by "High-risk subtype detection panels" |
| non high-risk group | – | Diagnostic Test: High-risk subtype detection panelsSelected by "High-risk subtype detection panels" |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with acute leukemia (newly diagnosis)
Key inclusion criteria (1 listed)
- Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment
Key exclusion criteria (1 listed)
- chronic leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-risk subtype detection panelsThe designed detection technology were used to identify the high-risk patients cohort. | Diagnostic test | high-risk group, non high-risk group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Acute, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.