DHPLC Determination of TPMT Polymorphisms.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00402090
Recruitment Status : Unknown
Verified November 2006 by National Institute of Cancerología.
Recruitment status was:  Recruiting
First Posted : November 22, 2006
Last Update Posted : November 22, 2006
Information provided by:
National Institute of Cancerología

Brief Summary:
TPMT is a key enzyme in the metabolism of thiopurines. TPMT polymorphisms have been described and are associated with a decrease activity of such enzyme. Therefore, a higher risk of developing toxicity is present in patients requiring these drugs, which are indicated in acute lymphoblastic leukemia, as well as, immunosuppressors after organ transplantation. The frequency of heterozygotes polymorphisms ranges from 3 till 12 %, in different populations. Homozygous patients have a lower frequency, estimated 1 in 300 individuals. The frequency of such polymorphisms in mestizos mexican population has not been analyzed, and we considered important to determine this frequency in healthy and patients requiring thiopurines, particularly acute lymphoblastic leukemia.

Condition or disease
Acute Lymphoblastic Leukemia

Detailed Description:

Objectives: Determine by DHPLC analysis the frequency of TPMT polymorphisms in mestizos mexican population with acute lymphoblastic leukemia.

  • To do a clinical correlation between the presence of polymorphism and thiopurine related- myelotoxicity.
  • Inclusion criteria: Healthy volunteers or patients with acute lymphoblastic leukemia, age > 18 years, who attend to the National Institute of Cancerologia.
  • Exclussion criteria: Patients with ALL, who are unable to have an adequate follow-up.
  • Samples: Genomic DNA from peripheral blood leukocytes was isolated by standard methods. Known (wild-type and polymorphic) sequenced polymerase chain reaction (PCR) fragments of the TPMT gene were used as controls. TPMT gene fragments were amplified. PCR products were then analyzed by denaturating high performance liquid chromatography (DHPLC).

Study Type : Observational
Enrollment : 160 participants
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Prevention of Thiopurines Related Toxicity Through the Determination by DHPLC TPMT Polymorphisms in Patients With ALL.
Study Start Date : April 2005
Study Completion Date : November 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy and patientes with acute lymphoblastic leukemia.
  • Age: older than 18 years.
  • Attend to the National Institute of Cancerologia

Exclusion Criteria:

  • Foreign patients with an irregular attendance to the National Institute of Cancerologia

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 identifier (NCT number): NCT00402090

Contact: Myrna Candelaria, MD (52)55-56280479

National Institute of Cancerologia Recruiting
MExico city, DF, Mexico, 14080
Contact: Myrna Candelaria, MD    (52)55-5628-04-79   
Principal Investigator: Myrna Candelaria, MD         
Sponsors and Collaborators
National Institute of Cancerología
Principal Investigator: Myrna Candelaria, MD National Institute of Cancerologia Identifier: NCT00402090     History of Changes
Other Study ID Numbers: 005/007/ICI
CONACYT: Salud-2004-01-005
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: November 22, 2006
Last Verified: November 2006

Keywords provided by National Institute of Cancerología:
thiopurine methyl transferase

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