NCT01761682

Brief Summary

The investigators would like to propose a prospective longitudinal observational cohort study for patients who will be diagnosed and/or treated for acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other retrospective analysis.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

3.3 years

First QC Date

January 3, 2013

Last Update Submit

July 19, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    10 year

Secondary Outcomes (2)

  • Event-free survival

    10 years

  • Relapse-free survival

    10 years

Study Arms (3)

Ph-ALL

Diagnosed as ALL with Philadelphia-negative

Other: Diagnosed as ALL

Ph+ALL

Diagnosed as ALL with Philadelphia-positive (including biphenotypic acute leukemia with Philadelphia-positive)

Other: Diagnosed as ALL

Other ALL

Diagnosed as ALL of other type, including Burkitt leukemia

Other: Diagnosed as ALL

Interventions

All patients who will be enrolled in this prospective registry are confined to those who are diagnosed as acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea, from Jan 2013 till Dec 2047

Also known as: Diagnosed as acute lymphoblastic leukemia
Other ALLPh+ALLPh-ALL

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are diagnosed and/or treated with acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea

You may qualify if:

  • All patients who are diagnosed and/or treated as acute lymphoblastic leukemia at Asan Medical Center (including biphenotypic acute leukemia with Philadelphila-positive, Burkitt leukemia/lymphoma)
  • years of age and over
  • All patients who give written consent according to guidelines at Asan Medical Center committee on human research

You may not qualify if:

  • Patients who refuse to give consent to registering

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow aspirate or peripheral blood (for its mononuclear cells) will be collected, processed, and cryopreserved for future analysis of DNA or cell culture. Acquisition of biospecimens will be proceeded if patient agree with the informed consent for donation of biospecimen to 'Asan Medical Center Biomaterial Resource Banking Center'. This registry data will be used as a basic demographic and clinical information for the biospecimens.

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaPrecursor B-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Biphenotypic, Acute

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Dae-Young Kim, MD, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 7, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 20, 2018

Record last verified: 2018-07

Locations