Neurofibromatosis Type 1 Brain Tumor Genetic Risk

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01707836

Collaborator

(none)

176

Enrollment

Location

55.2

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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

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.

Condition or Disease	Intervention/Treatment	Phase
Neurofibromatosis Type 1 Pediatric Brain Tumor

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.

Study Design

Study Type:

Observational

Actual Enrollment :

176 participants

Observational Model:

Family-Based

Time Perspective:

Cross-Sectional

Official Title:

Genetic Variation and Risk of Pediatric Brain Cancers

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

May 8, 2017

Actual Study Completion Date :

May 8, 2017

Arms and Interventions

Arm	Intervention/Treatment
Family Families with a child with Neurofibromatosis Type 1 who has been diagnosed with a brain tumor.

Outcome Measures

Primary Outcome Measures

Brain Tumor [September 1, 2012-February 1, 2014]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University	Saint Louis	Missouri	United States	63130

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator: Kimberly J Johnson, PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT01707836

Other Study ID Numbers:

201208141

First Posted:

Oct 16, 2012

Last Update Posted:

May 9, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2017