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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01761682
Other study ID # AMC-HEMREG-ALL
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 2013
Est. completion date May 2016

Study information

Verified date July 2018
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

1. Acquisition of informed concent form

2. Data acquisition from medical record including

- demographic / disease-associated factors

- details of treatment, and its results

- complications during treatment

- genetic data

- survival outcome (upto 10 years)

3. Accumulation of data for 30 years

4. Use of data for other retrospective analysis (including Asan Medical center Cell Banking basic data)


Recruitment information / eligibility

Status Terminated
Enrollment 200
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria:

- 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)

- 15 years of age and over

- All patients who give written consent according to guidelines at Asan Medical Center committee on human research

Exclusion Criteria:

- Patients who refuse to give consent to registering

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Diagnosed as ALL
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

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival 10 year
Secondary Event-free survival Definition of events will be as 'relapse', 'death from any cause'. Relapse will be defined as hematologic relapse and molecular relapse, respectively when the patient is diagnosed as Philadelphia-positive acute lymphoblastic leukemia 10 years
Secondary Relapse-free survival Relapse will be defined as hematologic relapse and molecular relapse, respectively when the patient is diagnosed as Philadelphia-positive acute lymphoblastic leukemia 10 years
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