NGS Monitor MRDNCT04126967
Next Generation Sequencing（NGS）Monitors Minimal Residual Disease（MRD）in Allo-PBSCT Patients
A study testing NGS patients in people with NGS Monitor MRD, run by Xianmin Song, MD at 1 site in China.
Trial summary
Objective: to evaluate the value of high-throughput next generation gene sequencing (NGS) in the detection of minimal residual disease (MRD) and recurrence after allogeneic transplantation. Overview of study design. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NGS Monitor MRD
- What is being tested?
- NGS patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 31 Dec 2023
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old, male or female;
- Patients who received allogeneic peripheral blood hematopoietic stem cell transplantation ;
- Patients must be able to understand and be willing to participate in this study and sign informed consent.-
Who cannot join
- Non-allogeneic hematopoietic stem cell transplantation patients;
- The expected survival rate is less than 3 months after transplantation;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Xianmin Song, PHD,MD, 86-18616705298, Shongxm@sjtu.edu.cn
About this study
Objective: to evaluate the value of high-throughput next generation gene sequencing (NGS) in the detection of minimal residual disease (MRD) and recurrence after allogeneic transplantation.
Overview of study design. This study is a single-center, single-arm, prospective clinical trial designed to evaluate the significance of next generation gene sequencing (NGS) in monitoring for minimal residual disease (MRD) and recurrence after allogeneic transplantation.
Read more
This clinical study is observational and does not involve drugs. Next generation sequencing (NGS) were used to monitor minor residual lesions after allogeneic hematopoietic stem cell transplantation, to predict disease recurrence early, and to monitor and evaluate prognosis, so as to provide basis for early intervention treatment after transplantation, so as to reduce hematological recurrence and improve survival rate.
This clinical study is observational and does not involve drugs.The sensitive next generation sequencing (NGS) was used to monitor the minimal residual lesions after allogeneic hematopoietic stem cell transplantation, to predict the relapse of the disease in the early stage, and to monitor and evaluate the prognosis, so as to provide the basis for early intervention treatment after transplantation, so as to reduce the hematological relapse and improve the survival rate.
Read the detailed description
Minimal residual disease (MRD) detection is the detection of residual micro-clones in patients with leukemia in remission, predicting the recurrence of the disease, and determining the next treatment of the disease.There are many methods to detect MRD, the most common one is Flow cytometry (FCM).The fusion genes of Wilms tumor 1（WT1）, pml-rara, runx1-runx1t1, cbfb-myh11 and nucleophosmin(NPM1) were detected by Polymerase Chain Reaction(PCR).Chromosome analysis;Fluorescence in situ hybridization（FISH）, etc.FCM is a commonly used method for clinical detection of MRD, with a sensitivity of 10-3~ 4. Its specificity is only high when there is abnormal cloning in specimens, and false negative can be caused when there is phenotypic drift and bone marrow dilution.PCR detection of WT1 is considered to be a marker of preleukaemia, but WT1 is also expressed in non-leukemic cells and is not recommended by the European leukaemia network (ELN).PCR detection of pml-rara, runx1-runx1t1, cbfb-myh11 and other fused genes only supported the clinical trial data when the log index decreased in the numerical procedure.Chromosome analysis is less sensitive because of its lack of metaphase chromosome division.FISH has a sensitivity of 10-2~ 3, specificity is only high in abnormal cells, but detection rate of mutations not covered by probes is low, and non-specific binding of probes can lead to false positives.The sensitivity, specificity and pertinence of various MRD detection technologies are different. Currently, these technologies are combined to analyze MRD clinically.
Next generation gene sequencing (NGS) is the ability to simultaneously detect the structure of all disease clones and subclones and track their changing mutations.Compared with PCR and FCM that detect abnormalities in a single clone, NGS can detect each disease clone and subclone.NGS has been clinically used to diagnose mutations and subtypes of blood diseases.Persistent mutations are associated with high recurrence rates.
This clinical study is observational and does not involve drugs.The sensitive next generation sequencing (NGS) was used to monitor the minimal residual lesions after allogeneic hematopoietic stem cell transplantation, to predict the relapse of the disease in the early stage, and to monitor and evaluate the prognosis, so as to provide the basis for early intervention treatment after transplantation, so as to reduce the hematological relapse and improve the survival rate.
- Conditions
- NGS Monitor MRD
- Being tested
- NGS patients
- Keywords
- NGS, MRD, Allo-PBSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGS patientsDiagnostic test
The next generation sequencing technique (NGS) was used to monitor the minimal residual lesions after allogeneic hematopoietic stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| allo-PBSCT patients with no NGS text | Other | Not described Receives: Diagnostic Test: NGS patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
NGS results
positive: VAF>0.2%; negative: VAF <0.1%
Measured: 3 years
MRD by FCM
posotive：MRD by FCM≥0.01%， negative:MRD by FCM<0.01%
Measured: 3 years
Donor chimerism (DC)
positive: the chimerism rate increased ((STR < 90%) or FISH > 0.6%);negative:chimerism rate reached(STR > 95% or xy-FISH Donor chromosome > 99.4%)
Measured: 3 years
fusion gene or WT1
positive:WT1/ reference gene, bone marrow >2%;negative:negative fusion gene, WT1/ reference gene <0.6%.
Measured: 3 years
relapse
The number of patients relapse after Allo-PBSCT
Measured: 3 years
Secondary outcomes (1)
survival
overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NGS Monitor MRDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xianmin Song, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126967
- Sponsor's protocol ID
- SHSYXY- NGS-2019003
- Status last verified
- Oct 2019
- First submitted
- 7 Oct 2019
- Last updated
- 15 Oct 2019
- 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 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Generation Sequencing（NGS）Monitors Minimal Residual Disease（MRD）in Allo-PBSCT Patients
- ClinicalTrials.gov ID
- NCT04126967
- Acronym / sponsor ID
- SHSYXY- NGS-2019003
- Conditions
- NGS Monitor MRD
- Keywords
- NGS, MRD, Allo-PBSCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xianmin Song, MDUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Oct 2019 (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.
Objective: to evaluate the value of high-throughput next generation gene sequencing (NGS) in the detection of minimal residual disease (MRD) and recurrence after allogeneic transplantation.
Overview of study design. This study is a single-center, single-arm, prospective clinical trial designed to evaluate the significance of next generation gene sequencing (NGS) in monitoring for minimal residual disease (MRD) and recurrence after allogeneic transplantation.
This clinical study is observational and does not involve drugs. Next generation sequencing (NGS) were used to monitor minor residual lesions after allogeneic hematopoietic stem cell transplantation, to predict disease recurrence early, and to monitor and evaluate prognosis, so as to provide basis for early intervention treatment after transplantation, so as to reduce hematological recurrence and improve survival rate.
This clinical study is observational and does not involve drugs.The sensitive next generation sequencing (NGS) was used to monitor the minimal residual lesions after allogeneic hematopoietic stem cell transplantation, to predict the relapse of the disease in the early stage, and to monitor and evaluate the prognosis, so as to provide the basis for early intervention treatment after transplantation, so as to reduce the hematological relapse and improve the survival rate.
Detailed description
Minimal residual disease (MRD) detection is the detection of residual micro-clones in patients with leukemia in remission, predicting the recurrence of the disease, and determining the next treatment of the disease.There are many methods to detect MRD, the most common one is Flow cytometry (FCM).The fusion genes of Wilms tumor 1（WT1）, pml-rara, runx1-runx1t1, cbfb-myh11 and nucleophosmin(NPM1) were detected by Polymerase Chain Reaction(PCR).Chromosome analysis;Fluorescence in situ hybridization（FISH）, etc.FCM is a commonly used method for clinical detection of MRD, with a sensitivity of 10-3~ 4. Its specificity is only high when there is abnormal cloning in specimens, and false negative can be caused when there is phenotypic drift and bone marrow dilution.PCR detection of WT1 is considered to be a marker of preleukaemia, but WT1 is also expressed in non-leukemic cells and is not recommended by the European leukaemia network (ELN).PCR detection of pml-rara, runx1-runx1t1, cbfb-myh11 and other fused genes only supported the clinical trial data when the log index decreased in the numerical procedure.Chromosome analysis is less sensitive because of its lack of metaphase chromosome division.FISH has a sensitivity of 10-2~ 3, specificity is only high in abnormal cells, but detection rate of mutations not covered by probes is low, and non-specific binding of probes can lead to false positives.The sensitivity, specificity and pertinence of various MRD detection technologies are different. Currently, these technologies are combined to analyze MRD clinically.
Next generation gene sequencing (NGS) is the ability to simultaneously detect the structure of all disease clones and subclones and track their changing mutations.Compared with PCR and FCM that detect abnormalities in a single clone, NGS can detect each disease clone and subclone.NGS has been clinically used to diagnose mutations and subtypes of blood diseases.Persistent mutations are associated with high recurrence rates.
This clinical study is observational and does not involve drugs.The sensitive next generation sequencing (NGS) was used to monitor the minimal residual lesions after allogeneic hematopoietic stem cell transplantation, to predict the relapse of the disease in the early stage, and to monitor and evaluate the prognosis, so as to provide the basis for early intervention treatment after transplantation, so as to reduce the hematological relapse and improve the survival rate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| allo-PBSCT patients with no NGS text | Other | Diagnostic Test: NGS patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years old, male or female;
- Patients who received allogeneic peripheral blood hematopoietic stem cell transplantation ;
- Patients must be able to understand and be willing to participate in this study and sign informed consent.-
Key exclusion criteria (2 listed)
- Non-allogeneic hematopoietic stem cell transplantation patients;
- The expected survival rate is less than 3 months after transplantation;
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 |
|---|---|---|
| NGS patientsThe next generation sequencing technique (NGS) was used to monitor the minimal residual lesions after allogeneic hematopoietic stem cell transplantation | Diagnostic test | allo-PBSCT patients with no NGS text |
Primary outcome
NGS results
Time frame: 3 years
positive: VAF>0.2%; negative: VAF <0.1%
MRD by FCM
Time frame: 3 years
posotive：MRD by FCM≥0.01%， negative:MRD by FCM<0.01%
Donor chimerism (DC)
Time frame: 3 years
positive: the chimerism rate increased ((STR < 90%) or FISH > 0.6%);negative:chimerism rate reached(STR > 95% or xy-FISH Donor chromosome > 99.4%)
fusion gene or WT1
Time frame: 3 years
positive:WT1/ reference gene, bone marrow >2%;negative:negative fusion gene, WT1/ reference gene <0.6%.
relapse
Time frame: 3 years
The number of patients relapse after Allo-PBSCT
1 secondary outcome
survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NGS patients in people with NGS Monitor MRD, run by Xianmin Song, MD 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NGS results (time frame: 3 years). The study lists 5 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 15 Oct 2019.