NCT02344966

Brief Summary

The objective of this study is to evaluate the prognostic factors of acute leukemia patients 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 diagnosis process, treatment and/or thereafter

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

9.7 years

First QC Date

December 30, 2014

Last Update Submit

March 14, 2019

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    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.

    10years

Secondary Outcomes (3)

  • Progression-free survival

    10years

  • Treatment-related mortality

    10years

  • Complete remission rate

    10 years

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sampling is performed in patients diagnosed with acute leukemia 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 1100 considering annual incidence rate.

You may qualify if:

  • Patients diagnosed with acute leukemia in Severance Hospital.
  • Both genders of 16 Years and older
  • sign a written informed consent document

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

Central Study Contacts

JUNE-WON CHEONG, MD

CONTACT

82-2-2228-1970JWCHONG70@yuhs.ac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2014

First Posted

January 26, 2015

Study Start

June 1, 2011

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

March 18, 2019

Record last verified: 2019-03

Locations

KR(1)