Genomic Changes in Childhood Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
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
  Purpose

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
Acute Lymphoblastic Leukemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Genomics Evolution in Childhood Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA

bone marrow, peripheral blood


Estimated Enrollment: 400
Study Start Date: April 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Lin Dong-Tsamn, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01089907     History of Changes
Other Study ID Numbers: 200906028R
Study First Received: March 17, 2010
Last Updated: March 18, 2010
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on September 14, 2014