Identification of Genomic Changes in Families Having Mult... | NCT02386241

Studies
Identification of Genomic Changes in Families Having Multiple Members With Tumors

NCT02386241

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Status

Terminated

Last Update Posted

Apr 19, 2024Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Glioma

Interventions

saliva or blood sample collection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI departure without replacement

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Jul 31, 2019Actual

Completion Date

Jul 31, 2019Actual

First Submitted Date

Mar 5, 2015

First Submission Date that Met QC Criteria

Mar 10, 2015

First Posted Date

Mar 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2024

Last Update Posted Date

Apr 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lori Wood, Research Operations Manager, St. Joseph's Hospital and Medical Center, PhoenixPrincipal Investigator

Lead Sponsor

St. Joseph's Hospital and Medical Center, PhoenixOTHER

Collaborators

Name	Class
Translational Genomics Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
saliva or blood sample collection	Other	Single saliva or blood sample measuring 10mL for genomic analysis.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	within 30 days of blood or saliva collection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

less than 18 years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Families having multiple members (1st degree) with tumors.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Nakaji, MD	Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barrow Neurological Institute at St. Joseph's Hospital Medical Center		Phoenix	Arizona	85013	United States

Condition Browse Module

MeSH Terms

ID	Term
D005910	Glioma
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided