- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02386241
Identification of Genomic Changes in Families Having Multiple Members With Tumors
April 17, 2024 updated by: Lori Wood, St. Joseph's Hospital and Medical Center, Phoenix
This study will compare genomic alterations between the parents and the patients with high-grade glioma.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85013
- Barrow Neurological Institute at St. Joseph's Hospital Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Families having multiple members (1st degree) with tumors.
Description
Inclusion Criteria:
- 18 years or older.
- Family history of brain tumor in first degree relative
Exclusion Criteria:
- less than 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total genomic sequencing
Time Frame: within 30 days of blood or saliva collection
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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.
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within 30 days of blood or saliva collection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Peter Nakaji, MD, Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
March 5, 2015
First Submitted That Met QC Criteria
March 10, 2015
First Posted (Estimated)
March 11, 2015
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14BN108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.