GliomaNCT02386241
Identification of Genomic Changes in Families Having Multiple Members With Tumors
An observational study of Glioma, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial summary
This study will compare genomic alterations between the parents and the patients with high-grade glioma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioma
- What is being tested?
- saliva or blood sample collection
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Families having multiple members (1st degree) with tumors.
Who may be able to join
- 18 years or older.
- Family history of brain tumor in first degree relative
Who cannot join
- less than 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Barrow Neurological Institute at St. Joseph's Hospital Medical Center
Phoenix, Arizona, 85013
About this study
This study will compare genomic alterations between the parents and the patients with high-grade glioma.
Read the 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.
- Conditions
- Glioma
- Being tested
- saliva or blood sample collection
- Keywords
- brain tumor
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva or blood sample collectionOther
Single saliva or blood sample measuring 10mL for genomic analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Total genomic sequencing
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.
Measured: within 30 days of blood or saliva collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Why it stopped: PI departure without replacement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Genomics Research Institute
- Responsible party
- Principal investigator, Lori Wood, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Peter Nakaji, MD, Principal investigator, Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386241
- Sponsor's protocol ID
- 14BN108
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2015
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genomic Changes in Families Having Multiple Members With Tumors
- ClinicalTrials.gov ID
- NCT02386241
- Acronym / sponsor ID
- 14BN108
- Conditions
- Glioma
- Keywords
- brain tumor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI departure without replacement
- Enrolment
- 4 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Collaborators
- Translational Genomics Research Institute
- Study start
- Mar 2015
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare genomic alterations between the parents and the patients with high-grade glioma.
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
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Families having multiple members (1st degree) with tumors.
Key inclusion criteria (2 listed)
- 18 years or older.
- Family history of brain tumor in first degree relative
Key exclusion criteria (1 listed)
- less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saliva or blood sample collectionSingle saliva or blood sample measuring 10mL for genomic analysis. | Other | – |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: PI departure without replacement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Nakaji, MD principal investigator
Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI departure without replacement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total genomic sequencing (time frame: within 30 days of blood or saliva collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.