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Prospective and Retrospective Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and During Treatment or Thereafter in Acute Leukemia (Acute Leukemia HSCT Cohort)

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ClinicalTrials.gov Identifier: NCT02344953
Recruitment Status : Recruiting
First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
The objective of this study is to evaluate the prognostic factors of acute leukemia patients received stem cell transplantation and to invent the molecular genetic test for sensitive detection of minimal residual disease, and thereby this study would contribute to plan the risk adapted treatment. Patients will have samples of blood and/or bone marrow collected during treatment or thereafter

Condition or disease
Acute Leukemia

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Study Start Date : January 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 10years ]
    Overall survival (OS) is defined as the time from date of diagnosis until death due to any cause within the follow-up period. Surviving patients are censored at date of last contact.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 10years ]
    Progression-free survival (PFS) is defined as survival without disease progression or relapse; patients alive without disease progression or relapse are censored on the last assessment date. Median OS and PFS are calculated using Kaplan-Meier estimates with a 95% confidence interval.

  2. Treatment-related mortality [ Time Frame: 10years ]
    Treatment-related mortality was defined as death unrelated to refractory or progressive disease occurring before first remission was achieved, or any death in complete remission

  3. Complete remission rate [ Time Frame: 10 years ]
    Response assessment is performed according to the criteria reported by BD Cheson et al. (Revised recommendations of the international working group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia)



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Sampling is performed in patients diagnosed with acute leukemia who underwent allo-HSCT in Severance Hospital.

Every eligible patients in peroid of study are enrolled. Patients must have the ability and willingness to sign a written informed consent document. Planned number of patients is 1000 considering annual incidence rate.

Criteria

Inclusion Criteria:

  • Patients diagnosed with acute leukemia who underwent allo-HSCT in Severance Hospital.
  • Both genders of 16 Years and older
  • sign a written informed consent document
  • exemption of consent in patient who died in study period.

Exclusion Criteria:

  • No comprehension or willingness to sign a written informed consent document.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344953


Contacts
Contact: JUNE-WON CHEONG, MD 82-2-2228-1970 JWCHONG70@yuhs.ac

Locations
Korea, Republic of
Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: JUNE-WON CHEONG, MD    82-2-2228-1970    JWCHONG70@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02344953     History of Changes
Other Study ID Numbers: 4-2010-0669
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2011

Additional relevant MeSH terms:
Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes