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Identification of Genomic Changes in Families Having Multiple Members With Tumors

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ClinicalTrials.gov Identifier: NCT02386241
Recruitment Status : Terminated (PI departure without replacement)
First Posted : March 11, 2015
Last Update Posted : June 15, 2021
Sponsor:
Collaborator:
Translational Genomics Research Institute
Information provided by (Responsible Party):
Norissa Honea, St. Joseph's Hospital and Medical Center, Phoenix

Study Description
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Brief Summary:
This study will compare genomic alterations between the parents and the patients with high-grade glioma.

Condition or disease Intervention/treatment
Glioma Other: saliva or blood sample collection

Detailed Description:
Genomic changes leading to the formation of brain tumors are slowly being discovered. Despite advances in genomic technology, much analysis is hindered by the lack of control samples that could better delineate genomic alterations leading to disease. The ideal genomic control would be the genetic material of the parents of afflicted individuals. The researchers propose to then compare the genomic material from parents of siblings, both of whom have a diagnosis of a high-grade glioma. Additionally, the researchers will then compare the genomic alterations between the parents and the patients. This analysis will provide an unprecedented insight into genomic level changes that take place between parents and patients that resulted in the formation of a high-grade glioma.
Study Design
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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Identification of Genomic Changes in Families Having Multiple Members With Tumors
Study Start Date : March 2015
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Groups and Cohorts
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Intervention Details:
  • Other: saliva or blood sample collection
    Single saliva or blood sample measuring 10mL for genomic analysis.

Outcome Measures
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Primary Outcome Measures :
  1. Total genomic sequencing [ Time Frame: within 30 days of blood or saliva collection ]
    Researchers will perform total genomic sequencing using next generation sequencing technology to identify common variants associated with familial brain tumors. Upon sequencing of the genomic material, the data analysis will be done using standard statistical methods. We will use bioinformatics tools (high throughput sequencing of genome) to identify genomic changes between parents and patients.


Biospecimen Retention:   Samples With DNA
A single saliva or blood sample measuring 10mL for genomic analysis.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Families having multiple members (1st degree) with tumors.
Criteria

Inclusion Criteria:

  • 18 years or older.
  • Family history of brain tumor in first degree relative

Exclusion Criteria:

  • less than 18 years
Contacts and Locations
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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): NCT02386241


Locations
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United States, Arizona
Barrow Neurological Institute at St. Joseph's Hospital Medical Center
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Translational Genomics Research Institute
Investigators
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Principal Investigator: Peter Nakaji, MD Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute
More Information
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Responsible Party: Norissa Honea, Research Clinician, St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT02386241    
Other Study ID Numbers: 14BN108
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
Keywords provided by Norissa Honea, St. Joseph's Hospital and Medical Center, Phoenix:
brain tumor