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Genomic Changes in Childhood Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT01089907
Recruitment Status : Unknown
Verified March 2010 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 19, 2010
Last Update Posted : March 19, 2010
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief 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.

Condition or disease
Acute Lymphoblastic Leukemia

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
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Genomics Evolution in Childhood Acute Lymphoblastic Leukemia
Study Start Date : April 2010
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : June 2013





Biospecimen Retention:   Samples With DNA
bone marrow, peripheral blood


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute lymphoblastic leukemia patients under 18 years of age
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089907


Contacts
Contact: Dong-Tsamn Lin, M.D. 02-23123456 ext 65399 dtlin@ntuh.gov.tw
Contact: young-li Yang, M.D. 02-23123456 ext 71311 yangylmd@gmail.com

Locations
Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 100
Contact: Dong-Tsamn Lin, M.D.    02-23123456 ext 65399    dtlin@ntuh.gov.tw   
Contact: Yong-li Yang, M.D.    02-23123456 ext 71732    yangylmd@gmail.com   
Principal Investigator: Dong-Tsamn Lin, M.D.         
Sub-Investigator: Young-li Yang, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Dong-Tsamn Lin, M.D. National Taiwan University Hospital,Taipei,Taiwan

Responsible Party: Lin Dong-Tsamn, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01089907     History of Changes
Other Study ID Numbers: 200906028R
First Posted: March 19, 2010    Key Record Dates
Last Update Posted: March 19, 2010
Last Verified: March 2010

Keywords provided by National Taiwan University Hospital:
genomic
childhood
acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases