DHPLC Determination of TPMT Polymorphisms. - Full Text View

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

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Convenience Sample, Prospective Study

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

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

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, DF
	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

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

Keywords provided by National Institute of Cancerología:

thiopurines

thiopurine methyl transferase

toxicity

pharmacogenomics

Study placed in the following topic categories:

Lymphatic Diseases

Leukemia

Leukemia, Lymphoid

Immunoproliferative Disorders

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Lymphoproliferative Disorders

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	National Institute of Cancerología
Information provided by:	National Institute of Cancerología
ClinicalTrials.gov Identifier:	NCT00402090