Neurofibromatosis Type 1 Brain Tumor Genetic Risk

Genetic Variation and Risk of Pediatric Brain Cancers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01707836

Enrollment

176

Registered

2012-10-16

Start date

2012-10-31

Completion date

2017-05-08

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurofibromatosis Type 1, Pediatric Brain Tumor

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

FAMILY_BASED

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Brain Tumor	September 1, 2012-February 1, 2014

Countries

United States

Outcome results