DHPLC Determination of TPMT Polymorphisms.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Institute of Cancerología.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Cancerología
ClinicalTrials.gov Identifier:
NCT00402090
First received: November 17, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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
Acute Lymphoblastic Leukemia

Study Type: Observational
Study Design: Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Prevention of Thiopurines Related Toxicity Through the Determination by DHPLC TPMT Polymorphisms in Patients With ALL.

Resource links provided by NLM:


Further study details as provided by National Institute of Cancerología:

Estimated Enrollment: 160
Study Start Date: April 2005
Estimated Study Completion Date: November 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402090

Contacts
Contact: Myrna Candelaria, MD (52)55-56280479 myrnac@prodigy.net.mx

Locations
Mexico
National Institute of Cancerologia Recruiting
MExico city, DF, Mexico, 14080
Contact: Myrna Candelaria, MD    (52)55-5628-04-79    myrnac@prodigy.net.mx   
Principal Investigator: Myrna Candelaria, MD         
Sponsors and Collaborators
National Institute of Cancerología
Investigators
Principal Investigator: Myrna Candelaria, MD National Institute of Cancerologia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00402090     History of Changes
Other Study ID Numbers: 005/007/ICI, CONACYT: Salud-2004-01-005
Study First Received: November 17, 2006
Last Updated: November 17, 2006
Health Authority: Mexico: Ethics Committee

Keywords provided by National Institute of Cancerología:
thiopurines
thiopurine methyl transferase
toxicity
pharmacogenomics

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

ClinicalTrials.gov processed this record on September 18, 2014