Acute Lymphoblastic LeukemiaNCT01089907
Genomic Changes in Childhood Acute Lymphoblastic Leukemia
An observational study of Acute Lymphoblastic Leukemia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To study the genomics with cell cycle and lymphocyte differentiation in disease, remission and relapse of childhood acute lymphoblastic leukemia. Then correlate these data with age, white cell count, cytogenetic changes, response to the chemotherapy and prognosis. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2010to Jun 2013
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Acute lymphoblastic leukemia patients under 18 years of age
Who may be able to join
- patients diagnosed as acute lymphoblastic leukemia
- age less than or equal to 18 years old
- signed informed consent
Who cannot join
- who is not acute lymphoblastic leukemia
- who did not sign informed consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Dong-Tsamn Lin, M.D., 02-23123456 ext. 65399, dtlin@ntuh.gov.tw
Yong-li Yang, M.D., 02-23123456 ext. 71732, yangylmd@gmail.com
About this study
Official title: Genomics Evolution in Childhood Acute Lymphoblastic Leukemia
To study the genomics with cell cycle and lymphocyte differentiation in disease, remission and relapse of childhood acute lymphoblastic leukemia. Then correlate these data with age, white cell count, cytogenetic changes, response to the chemotherapy and prognosis.
Read the detailed description
In order to know the genomic evolution of childhood acute lymphoblastic leukemia, we will collect bone marrow (10c.c.) at diagnosis, remission and relapse. We will do the following genes in addition to gene-chip including IKZF1,ETV6, EBF1, NR3C1, RAG1/G2, TCF3, BTLA, PAX5,LEF1, ERG and VPREB1.We will study the gene dosages and degree of methylation. The estimated patients numbers will be 300-400. Then we will correlate these data with patients'age, white blood cell count at diagnosis, cytogenetic abnormalities, response to the chemotherapy and prognosis.
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- genomic, childhood, acute lymphoblastic leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dong-Tsamn Lin, M.D., Principal investigator, National Taiwan University Hospital,Taipei,Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089907
- Sponsor's protocol ID
- 200906028R
- Status last verified
- Mar 2010
- First submitted
- 17 Mar 2010
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics Evolution in Childhood Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT01089907
- Acronym / sponsor ID
- 200906028R
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- genomic, childhood, acute lymphoblastic leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 19 Mar 2010 (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.
To study the genomics with cell cycle and lymphocyte differentiation in disease, remission and relapse of childhood acute lymphoblastic leukemia. Then correlate these data with age, white cell count, cytogenetic changes, response to the chemotherapy and prognosis.
Detailed description
In order to know the genomic evolution of childhood acute lymphoblastic leukemia, we will collect bone marrow (10c.c.) at diagnosis, remission and relapse. We will do the following genes in addition to gene-chip including IKZF1,ETV6, EBF1, NR3C1, RAG1/G2, TCF3, BTLA, PAX5,LEF1, ERG and VPREB1.We will study the gene dosages and degree of methylation. The estimated patients numbers will be 300-400. Then we will correlate these data with patients'age, white blood cell count at diagnosis, cytogenetic abnormalities, response to the chemotherapy and prognosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Acute lymphoblastic leukemia patients under 18 years of age
Key inclusion criteria (3 listed)
- patients diagnosed as acute lymphoblastic leukemia
- age less than or equal to 18 years old
- signed informed consent
Key exclusion criteria (2 listed)
- who is not acute lymphoblastic leukemia
- who did not sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2010.
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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.
Dong-Tsamn Lin, M.D. principal investigator
National Taiwan University Hospital,Taipei,Taiwan
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 Acute Lymphoblastic Leukemia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Mar 2010. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-Tsamn Lin, M.D. (02-23123456 ext. 65399, dtlin@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 19 Mar 2010.