Genetic Influences on Pediatric Brain Tumor Development in Neurofibromatosis Type 1
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Purpose
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 |
|---|
|
Neurofibromatosis Type 1 Pediatric Brain Tumor |
| Study Type: | Observational |
| Study Design: | Observational Model: Family-Based Time Perspective: Cross-Sectional |
| Official Title: | Genetic Variation in the Folate Pathway and Risk of Pediatric Brain Cancers |
Blood or saliva samples
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Family
Families with a child with Neurofibromatosis Type 1 who has been diagnosed with a 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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Families will be recruited from the Washingington University Neurofibromatosis-1 (NF1) Patient Registry Initiative (NPRI) and NF Center Clinic.
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| Contact: Kimberly Johnson, PhD, MPH | 314-935-9154 | kijohnson@brownschool.wustl.edu |
| Contact: Nancy Mueller, MPH | 314-935-5117 | nancymueller@wustl.edu |
| United States, Missouri | |
| Washington University | Recruiting |
| St. Louis, Missouri, United States, 63130 | |
| Principal Investigator: Kimberly J Johnson, PhD, MPH | |
| Principal Investigator: | Kimberly J Johnson, PhD | Washington University in St. Louis |
More Information
No publications provided
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01707836 History of Changes |
| Other Study ID Numbers: | 201208141 |
| Study First Received: | October 12, 2012 |
| Last Updated: | October 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Brain Neoplasms Neurofibromatosis 1 Osteitis Fibrosa Cystica Neurofibromatoses Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurofibroma Nerve Sheath Neoplasms |
Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplastic Syndromes, Hereditary Neurocutaneous Syndromes Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Genetic Diseases, Inborn Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013