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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01089907
Other study ID # 200906028R
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 17, 2010
Last updated March 18, 2010
Start date April 2010
Est. completion date June 2013

Study information

Verified date March 2010
Source National Taiwan University Hospital
Contact Dong-Tsamn Lin, M.D.
Phone 02-23123456
Email dtlin@ntuh.gov.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date June 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

1. patients diagnosed as acute lymphoblastic leukemia

2. age less than or equal to 18 years old

3. signed informed consent

Exclusion Criteria:

1. who is not acute lymphoblastic leukemia

2. who did not sign informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

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