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Thiopurine Methyltransferase Polymorphisms Evaluation

This study has been withdrawn prior to enrollment.
(Observational Study should not be in CT.gov)
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00166647
First received: September 9, 2005
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of the study is to determine the frequency of allelic variants in TPMT in the Hispanic population and to compare the frequency in the Hispanic population with the Caucasian Population.


Condition Intervention Phase
Cancer
 Procedure: Blood Sampling
 Phase 4

Study Type: Observational
Official Title: Evaluation of Thiopurine Methyltransferase Polymorphisms in the Hispanic Population

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Enrollment: 0
Study Start Date: February 2004
Detailed Description:

Relatively few studies have been performed evaluating the variant allele frequencies in Spanish populations. To date, no studies evaluating the TPMT variant allele frequency in the Hispanic population have been reported. Hispanics are a growing part of the patient population treated in the United States. Characterization of the proportion of patients with variant genotypes in this population is important since Hispanic children represent a significant proportion of children being treated with thiopurines.

A single 3 cc heparinized blood sample will be obtained for TPMT genotyping. The sample will be obtained either simultaneously with a clinical sample, at the time of an otherwise medically indicated intravenous catheter placement or scavenged from excess blood remaining following clinical laboratory testing.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Hispanic children and adolescents diagnosed and treated at Texas Children's Cancer Center within the last 5 years for malignant diseases/cancer and non-malignant hematological disorders that necessitate chemotherapy
  • All Hispanic children and adolescents who will be treated at Texas Children's Center for malignant diseases/cancer and non-malignant hematological disorders that will necessitate chemotherapy.

Exclusion Criteria:

  • Any child or adolescent registering at Texas Children's Cancer Center and not requiring any form of therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166647

Locations
United States, Texas
Baylor College of Medicine, Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Additional Information:
Pediatric Pharmacology Research Units Website  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00166647     History of Changes
Other Study ID Numbers: PPRU-10728
Study First Received: September 9, 2005
Last Updated: January 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Cancer
Chemotherapy
Hematological disorder

ClinicalTrials.gov processed this record on May 19, 2013