Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT

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Brief Title

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

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.
    



Study Type

Observational [Patient Registry]


Primary Outcome

1-year relapse rate after allo-HSCT

Secondary Outcome

 1-year recurrence-free survival (RFS)

Condition

Acute Myeloid Leukemia



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

500

Start Date

October 15, 2018

Completion Date

October 15, 2021

Primary Completion Date

October 15, 2020

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Depei Wu, doctor, 8613382108261, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03715621

Organization ID

AML-NGS-2018


Responsible Party

Principal Investigator

Study Sponsor

The First Affiliated Hospital of Soochow University


Study Sponsor

Depei Wu, doctor, Principal Investigator, The First Affiliated Hospital of Soochow University


Verification Date

October 2018