Genetic Influences on Pediatric Brain Tumor Development in Neurofibromatosis Type 1

This study is currently recruiting participants.
Verified November 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01707836
First received: October 12, 2012
Last updated: November 21, 2013
Last verified: November 2013

October 12, 2012
November 21, 2013
October 2012
December 2013   (final data collection date for primary outcome measure)
Brain Tumor [ Time Frame: September 1, 2012-February 1, 2014 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01707836 on ClinicalTrials.gov Archive Site
Not Provided
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Genetic Influences on Pediatric Brain Tumor Development in Neurofibromatosis Type 1
Genetic Variation in the Folate Pathway and Risk of Pediatric Brain Cancers

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.

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.

Observational
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Blood or saliva samples

Non-Probability Sample

Families will be recruited from the Washingington University Neurofibromatosis-1 (NF1) Patient Registry Initiative (NPRI) and NF Center Clinic.

  • Neurofibromatosis Type 1
  • Pediatric Brain Tumor
Not Provided
Family
Families with a child with Neurofibromatosis Type 1 who has been diagnosed with a brain tumor.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2013
December 2013   (final data collection date for primary outcome measure)

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

Both
up to 18 Years
No
Contact: Kimberly Johnson, PhD, MPH 314-935-9154 kijohnson@brownschool.wustl.edu
Contact: Nancy Mueller, MPH 314-935-5117 nancymueller@wustl.edu
United States
 
NCT01707836
201208141
No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Kimberly J Johnson, PhD Washington University School of Medicine
Washington University School of Medicine
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP