Clincosm LogoSign in Get a demo

DHPLC Determination of TPMT Polymorphisms.

Sponsor
National Institute of Cancerología (Other)
Overall Status
Unknown status
CT.gov ID
NCT00402090
Collaborator
(none)
160
Enrollment
1
Location
19
Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Time Perspective:
    Other
    Official Title:
    Prevention of Thiopurines Related Toxicity Through the Determination by DHPLC TPMT Polymorphisms in Patients With ALL.
    Study Start Date :
    Apr 1, 2005
    Study Completion Date :
    Nov 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 National Institute of Cancerologia MExico city DF Mexico 14080

      Sponsors and Collaborators

      • National Institute of Cancerología

      Investigators

      • Principal Investigator: Myrna Candelaria, MD, National Institute of Cancerologia

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00402090
      Other Study ID Numbers:
      • 005/007/ICI
      • CONACYT: Salud-2004-01-005
      First Posted:
      Nov 22, 2006
      Last Update Posted:
      Nov 22, 2006
      Last Verified:
      Nov 1, 2006
      Keywords provided by , ,
      thiopurines
      thiopurine methyl transferase
      toxicity
      pharmacogenomics
      Additional relevant MeSH terms:
      Precursor Cell Lymphoblastic Leukemia-Lymphoma

      Study Results

      No Results Posted as of Nov 22, 2006