Leukemia, Acute LymphoblasticNCT01761682
Acute Lymphoblastic Leukemia Registry at Asan Medical Center
An observational study of Leukemia, Acute Lymphoblastic and Precursor B-Cell Lymphoblastic Leukemia, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Leukemia, Acute Lymphoblastic, Precursor B-Cell Lymphoblastic Leukemia, Leukemia, Biphenotypic, Acute
- What is being tested?
- Diagnosed as ALL
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to May 2016
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are diagnosed and/or treated with acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea
Who may be able to join
- 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
Who cannot join
- Patients who refuse to give consent to registering
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Cohort Registry for Patients With Acute Lymphoblastic Leukemia at Asan Medical Center
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.
Read the detailed description
- Acquisition of informed concent form
- 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)
- Accumulation of data for 30 years
- Use of data for other retrospective analysis (including Asan Medical center Cell Banking basic data)
- Conditions
- Leukemia, Acute Lymphoblastic, Precursor B-Cell Lymphoblastic Leukemia, Leukemia, Biphenotypic, Acute, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive, Lymphoblastic Lymphoma
- Being tested
- Diagnosed as ALL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosed as ALLOther
Also called Diagnosed as acute lymphoblastic leukemia
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
| Study group | Role | What they receive |
|---|---|---|
| Ph-ALL | Diagnosed as ALL with Philadelphia-negative Receives: Other: Diagnosed as ALL | |
| Ph+ALL | Diagnosed as ALL with Philadelphia-positive (including biphenotypic acute leukemia with Philadelphia-positive) Receives: Other: Diagnosed as ALL | |
| Other ALL | Diagnosed as ALL of other type, including Burkitt leukemia Receives: Other: Diagnosed as ALL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 10 year
Secondary outcomes (2)
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
Measured: 10 years
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Acute LymphoblasticStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dae-Young Kim, Asan Medical Center
- Investigators
- Dae-Young Kim, MD, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761682
- Sponsor's protocol ID
- AMC-HEMREG-ALL
- Status last verified
- Jul 2018
- First submitted
- 3 Jan 2013
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Cohort Registry for Patients With Acute Lymphoblastic Leukemia at Asan Medical Center
- ClinicalTrials.gov ID
- NCT01761682
- Acronym / sponsor ID
- AMC-HEMREG-ALL
- Conditions
- Leukemia, Acute Lymphoblastic, Precursor B-Cell Lymphoblastic Leukemia, Leukemia, Biphenotypic, Acute, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive, Lymphoblastic Lymphoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Acquisition of informed concent form
- 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)
- Accumulation of data for 30 years
- Use of data for other retrospective analysis (including Asan Medical center Cell Banking basic data)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ph-ALL | – | Other: Diagnosed as ALLDiagnosed as ALL with Philadelphia-negative |
| Ph+ALL | – | Other: Diagnosed as ALLDiagnosed as ALL with Philadelphia-positive (including biphenotypic acute leukemia with Philadelphia-positive) |
| Other ALL | – | Other: Diagnosed as ALLDiagnosed as ALL of other type, including Burkitt leukemia |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are diagnosed and/or treated with acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who refuse to give consent to registering
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosed as ALLAlso: Diagnosed as acute lymphoblastic leukemiaAll 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 | Other | Other ALL, Ph+ALL, Ph-ALL |
Primary outcome
Overall survival
Time frame: 10 year
2 secondary outcomes
Event-free survival
Time frame: 10 years
Relapse-free survival
Time frame: 10 years
Results and safety
The study was stopped early (reason given: The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dae-Young Kim, MD, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Acute Lymphoblastic and Precursor B-Cell Lymphoblastic Leukemia, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 10 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.