- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01089907
Genomic Changes in Childhood Acute Lymphoblastic Leukemia
March 18, 2010 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dong-Tsamn Lin, M.D.
- Phone Number: 65399 02-23123456
- Email: dtlin@ntuh.gov.tw
Study Contact Backup
- Name: young-li Yang, M.D.
- Phone Number: 71311 02-23123456
- Email: yangylmd@gmail.com
Study Locations
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Contact:
- Dong-Tsamn Lin, M.D.
- Phone Number: 65399 02-23123456
- Email: dtlin@ntuh.gov.tw
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Contact:
- Yong-li Yang, M.D.
- Phone Number: 71732 02-23123456
- Email: yangylmd@gmail.com
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Principal Investigator:
- Dong-Tsamn Lin, M.D.
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Sub-Investigator:
- Young-li Yang, M.D.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Acute lymphoblastic leukemia patients under 18 years of age
Description
Inclusion Criteria:
- patients diagnosed as acute lymphoblastic leukemia
- age less than or equal to 18 years old
- signed informed consent
Exclusion Criteria:
- who is not acute lymphoblastic leukemia
- who did not sign informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dong-Tsamn Lin, M.D., National Taiwan University Hospital,Taipei,Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Anticipated)
January 1, 2013
Study Completion (Anticipated)
June 1, 2013
Study Registration Dates
First Submitted
March 17, 2010
First Submitted That Met QC Criteria
March 18, 2010
First Posted (Estimate)
March 19, 2010
Study Record Updates
Last Update Posted (Estimate)
March 19, 2010
Last Update Submitted That Met QC Criteria
March 18, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200906028R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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