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Neurofibromatosis Type 1 Brain Tumor Genetic Risk

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ClinicalTrials.gov Identifier: NCT01707836
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease
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 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 : October 2012
Primary Completion Date : May 8, 2017
Study Completion Date : May 8, 2017


Group/Cohort
Family
Families with a child with Neurofibromatosis Type 1 who has been diagnosed with a brain tumor.



Primary Outcome Measures :
  1. Brain Tumor [ Time Frame: September 1, 2012-February 1, 2014 ]

Biospecimen Retention:   Samples With DNA
Blood or saliva samples


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Families will be recruited from the Washingington University Neurofibromatosis-1 (NF1) Patient Registry Initiative (NPRI) and NF Center Clinic.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707836


Locations
United States, Missouri
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

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01707836     History of Changes
Other Study ID Numbers: 201208141
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Brain Neoplasms
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms