Neurofibromatosis Type 1 Brain Tumor Genetic Risk

Neurofibromatosis Type 1 Clinical Trial

Official title:

Genetic Variation and Risk of Pediatric Brain Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707836
• Other study ID #: 201208141
• Status: Completed
• Phase: N/A
• First received: October 12, 2012
• Last updated: May 8, 2017
• Start date: October 2012
• Est. completion date: May 8, 2017

Study information

• Verified date: May 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: May 8, 2017
• Est. primary completion date: May 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Neurofibromatosis Type 1
• Pediatric Brain Tumor

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Tumor		September 1, 2012-February 1, 2014