Measurable Residual DiseaseNCT06000306
MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT to Predict Patients at High Risk of Relapse
An observational study of Measurable Residual Disease, run by Zhejiang University at 1 site in China.
Trial summary
A study on the Effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Measurable Residual Disease
- What is being tested?
- Digital Droplet PCR
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Jul 2023
- 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 12 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD mornitoring in the early period of allo-HSCT
Who may be able to join
- The presence of at least one haematological tumour-associated mutation or fusion gene detected at diagnosis by NGS or real-time qPCR provided for posttransplant MRD monitoring;
- Successful stem cell engraftment
- Received at least one bone marrow MRD detection by ddPCR in +30 days to +120 days after HSCT;
- Age 12-70
Who cannot join
- Patients who relapsed or died before the first ddPCR monitoring;
- Patients with only germline mutations.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang
About this study
Official title: Measurable Residual Disease Monitoring by Digital Droplet PCR in the Early Period After Allogeneic Hematopoietic Stem Cell Transplantation to Predict Patients at High Risk of Relapse
A study on the Effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse
Read the detailed description
This is a retrospective and multicenter clinical study.This study is indicated for patients with hematological malignancies who underwent allo-HSCT. It aims to evaluate the effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse. 192 patients will be enrolled. The clinical end points include cumulative incidence of relapse, relapse-free survival, non-relapse mortality, and overall survival.
- Conditions
- Measurable Residual Disease
- Being tested
- Digital Droplet PCR
- Keywords
- droplet digital PCR, allogeneic hematopoietic stem cell transplantation, relapse
- Medical subject headings
- Neoplasm, Residual, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Droplet PCRDiagnostic test
Measurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period
| Study group | Role | What they receive |
|---|---|---|
| ddPCR MRD positivity | Not described Receives: Diagnostic Test: Digital Droplet PCR | |
| ddPCR MRD negativity | Not described Receives: Diagnostic Test: Digital Droplet PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of relapse (CIR)
The time from the date of transplantation to disease recurrence:
Disease recurrence, defined as one of the following:
Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.
Measured: At Year 2
Secondary outcomes (3)
Relapse-free survival (RFS)
The time from the date of treatment to the occurrence of any of the following:
- Death from any cause
- Disease recurrence
Measured: At Year 2
Non-relapse mortality (NRM)
Assessment of NRM at Year 2
Measured: At Year 2
Overall survival (OS)
Assessment of OS at Year 2
Measured: At Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jan 2018
- Primary completion31 Aug 2021
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Measurable Residual DiseaseStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000306
- Sponsor's protocol ID
- IIT20230588C-R1
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen W, Huang J, Zhao Y, Huang L, Yuan Z, Gu M, Xu X, Shi J, Luo Y, Yu J, Lai X, Liu L, Fu H, Bao C, Huang X, Zheng Z, Huang H, Hu X, Zhao Y. Measurable residual disease monitoring by ddPCR in the early posttransplant period complements the traditional MFC method to predict relapse after HSCT in AML/MDS: a multicenter retrospective study. J Transl Med. 2024 Apr 30;22(1):410. doi: 10.1186/s12967-024-05114-w.
PubMed 38689269
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurable Residual Disease Monitoring by Digital Droplet PCR in the Early Period After Allogeneic Hematopoietic Stem Cell Transplantation to Predict Patients at High Risk of Relapse
- ClinicalTrials.gov ID
- NCT06000306
- Acronym / sponsor ID
- IIT20230588C-R1
- Conditions
- Measurable Residual Disease
- Keywords
- droplet digital PCR, allogeneic hematopoietic stem cell transplantation, relapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 21 Aug 2023 (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.
A study on the Effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse
Detailed description
This is a retrospective and multicenter clinical study.This study is indicated for patients with hematological malignancies who underwent allo-HSCT. It aims to evaluate the effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse. 192 patients will be enrolled. The clinical end points include cumulative incidence of relapse, relapse-free survival, non-relapse mortality, and overall survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ddPCR MRD positivity | – | Diagnostic Test: Digital Droplet PCR |
| ddPCR MRD negativity | – | Diagnostic Test: Digital Droplet PCR |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD mornitoring in the early period of allo-HSCT
Key inclusion criteria (4 listed)
- The presence of at least one haematological tumour-associated mutation or fusion gene detected at diagnosis by NGS or real-time qPCR provided for posttransplant MRD monitoring;
- Successful stem cell engraftment
- Received at least one bone marrow MRD detection by ddPCR in +30 days to +120 days after HSCT;
- Age 12-70
Key exclusion criteria (2 listed)
- Patients who relapsed or died before the first ddPCR monitoring;
- Patients with only germline mutations.
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 |
|---|---|---|
| Digital Droplet PCRMeasurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period | Diagnostic test | ddPCR MRD negativity, ddPCR MRD positivity |
Primary outcome
Cumulative incidence of relapse (CIR)
Time frame: At Year 2
The time from the date of transplantation to disease recurrence: Disease recurrence, defined as one of the following: Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.
3 secondary outcomes
Relapse-free survival (RFS)
Time frame: At Year 2
Non-relapse mortality (NRM)
Time frame: At Year 2
Overall survival (OS)
Time frame: At Year 2
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 22 Aug 2023.
- Derived from this study: PubMed 38689269Chen W, Huang J, Zhao Y, Huang L, Yuan Z, Gu M, Xu X, Shi J, Luo Y, Yu J, Lai X, Liu L, Fu H, Bao C, Huang X, Zheng Z, Huang H, Hu X, Zhao Y. Measurable residual disease monitoring by ddPCR in the early posttransplant period complements the traditional MFC method to predict relapse after HSCT in AML/MDS: a multicenter retrospective study. J Transl Med. 2024 Apr 30;22(1):410. doi: 10.1186/s12967-024-05114-w.
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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 Measurable Residual Disease, run by Zhejiang University 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 4 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: finished, as of the sponsor's last update on 22 Aug 2023. 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?
Cumulative incidence of relapse (CIR) (time frame: At Year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06000306, which also lists 1 linked publication.
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 22 Aug 2023.