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DHPLC Determination of TPMT Polymorphisms.

NCT ID: NCT00402090

Last Updated: 2006-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-11-30

Brief Summary

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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

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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).

Conditions

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Acute Lymphoblastic Leukemia

Keywords

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thiopurines thiopurine methyl transferase toxicity pharmacogenomics

Study Design

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Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Cancerología

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Myrna Candelaria, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cancerologia

Locations

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National Institute of Cancerologia

Mexico City, Mexico City, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Myrna Candelaria, MD

Role: CONTACT

Phone: (52)55-56280479

Email: [email protected]

Facility Contacts

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Myrna Candelaria, MD

Role: primary

Other Identifiers

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CONACYT: Salud-2004-01-005

Identifier Type: -

Identifier Source: secondary_id

005/007/ICI

Identifier Type: -

Identifier Source: org_study_id