Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Genomic Changes in Childhood Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01089907
First received: March 17, 2010
Last updated: March 18, 2010
Last verified: March 2010

March 17, 2010
March 18, 2010
April 2010
January 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Genomic Changes in Childhood Acute Lymphoblastic Leukemia
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
bone marrow, peripheral blood
Non-Probability Sample
Acute lymphoblastic leukemia patients under 18 years of age
Acute Lymphoblastic Leukemia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
400
June 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
up to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01089907
200906028R
Yes
Not Provided
Not Provided
Lin Dong-Tsamn, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Dong-Tsamn Lin, M.D. National Taiwan University Hospital,Taipei,Taiwan
National Taiwan University Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP