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Spots Global Cancer Trial Database for DHPLC Determination of TPMT Polymorphisms.

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Trial Identification

Brief Title: DHPLC Determination of TPMT Polymorphisms.

Official Title: Prevention of Thiopurines Related Toxicity Through the Determination by DHPLC TPMT Polymorphisms in Patients With ALL.

Study ID: NCT00402090

Interventions

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.

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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

National Institute of Cancerologia, MExico city, DF, Mexico

Contact Details

Name: Myrna Candelaria, MD

Affiliation: National Institute of Cancerologia

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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