Clinical trial NCT03715621: Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT
Official title: A Study of Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
next generation sequencing
Hematopoietic Stem Cell Transplantation
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with the diagnosis of AML who is going to receive an allo-geneic HSCT within 30 days

Brief summary: Acute myeloid leukemia (AML) is a genetically heterogeneous disease and allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment option for AML except for AML-M3. Relapse remains the major cause of treatment failure after allo-HSCT. Molecular residual disease has been shown to be a strong risk factor for relapse after HSCT. In this study, the investigators will detect mutations before/after allo-HSCT by using next-generation sequencing (NGS) technique to measure residual disease and evaluate the prognostic impact of molecular residual disease in a cohort of AML participants receiving allo-HSCT.


Eligibility criteria: Inclusion Criteria:

* 18 years or old;
* Clinical diagnosis of acute myeloid leukemia (AML);
* Availabe records of MICM and NGS results at diagnosis;
* Be going to receive allo-HSCT.

Exclusion Criteria:

* Active malignancy;
* Pregnant or breast feeding women.

Primary outcomes:
measure: 1-year relapse rate after allo-HSCT
timeFrame: 1 year after allo-HSCT
Secondary outcomes:
measure: 1-year recurrence-free survival (RFS)
timeFrame: 1 year after allo-HSCT
measure: 1-year overall survival (OS)
timeFrame: 1 year after allo-HSCT
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First affiliated Hospital of SooChow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Depei Wu, doctor
role: PRINCIPAL_INVESTIGATOR
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