Overview

This trial is active, not recruiting.

Conditions neurofibromatosis type 1, pediatric brain tumor
Sponsor Washington University School of Medicine
Start date October 2012
End date June 2017
Trial size 40 participants
Trial identifier NCT01707836, 201208141

Summary

This study will analyze DNA samples to determine associations between maternal and offspring genetic factors and pediatric brain tumor development in children with Neurofibromatosis Type 1. Participating families (mother, father, child) will be asked to complete a short questionnaire and provide DNA samples (either saliva or blood). The information gained from your participation may one day help doctors develop strategies to reduce brain tumor risk in individuals with NF1. Please note: there is no therapy associated with this study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model family-based
Time perspective cross-sectional
Arm
Families with a child with Neurofibromatosis Type 1 who has been diagnosed with a brain tumor.

Primary Outcomes

Measure
Brain Tumor
time frame: September 1, 2012-February 1, 2014

Eligibility Criteria

Male or female participants up to 18 years old.

Inclusion Criteria: - Pediatric participant (born during 1994-2012) with NF1 and diagnosed with a brain tumor - Biological mother or father (or full sibling if mother or father is unable to participate) able to participate - All family members (pediatric participant, biological mother, and biological father or full sibling) must be willing to contribute a blood or saliva sample - ability to understand consent forms Exclusion Criteria: -those who do not meet inclusion criteria

Additional Information

Official title Genetic Variation and Risk of Pediatric Brain Cancers
Principal investigator Kimberly J Johnson, PhD
Description The prenatal period is a developmentally vulnerable time point during which environmental conditions, including nutrition, can have life-long impacts on health.1,2 This is particularly relevant to many childhood cancers that are thought to initiate during pregnancy.3 As a consequence, there has been intense interest in whether prenatal exposures can modulate childhood cancer risk.4-6 It is important to recognize that both maternal and offspring genetic factors including those in nutritional pathways may play an important role in pediatric cancer risk through their effect on the child's exposure to nutrients important in development during the prenatal period. The purpose of this research study is to evaluate whether there are any maternal or offspring genetic factors in the folate pathway that may contribute to the development of brain tumors in children with Neurofibromatosis Type 1 through analysis of DNA samples collected from families.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.