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Status unknownNCT00402090Updated Nov 22, 2006

DHPLC Determination of TPMT Polymorphisms.

An observational study in Acute Lymphoblastic Leukemia, sponsored by National Institute of Cancerología. Status unknown at 1 site in Mexico. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-11-22.

Sponsored by National Institute of Cancerología · Observational

The sponsor has not verified this record recently (last verified Nov 2006), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Other
Enrollment
160
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).
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Conditions studied

  • Acute Lymphoblastic Leukemia

Keywords

  • thiopurines
  • thiopurine methyl transferase
  • toxicity
  • pharmacogenomics
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In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.

This study's enrollment of 160 is above the median of 120 across 300 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

National Institute of Cancerología is the lead sponsor of 38 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Foreign patients with an irregular attendance to the National Institute of Cancerologia
05

Study design

Time perspective
Other
Enrollment
160 participants
06

Study locations

1 of 1 sites recruiting
  • National Institute of Cancerologia
    MExico city, DF 14080, Mexico
    • Myrna Candelaria, MD · Contact · myrnac@prodigy.net.mx · (52)55-5628-04-79
    • Myrna Candelaria, MD · Principal investigator
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00402090
Lead sponsor
National Institute of Cancerología
First posted
Nov 22, 2006
Start date
Apr 2005
Completion
Nov 2006
Last update
Nov 22, 2006

Study contacts

Myrna Candelaria, MD
Contact
myrnac@prodigy.net.mx
(52)55-56280479
Myrna Candelaria, MD
principal investigator · National Institute of Cancerologia
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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