NCT02386241

Brief Summary

This study will compare genomic alterations between the parents and the patients with high-grade glioma.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

4.4 years

First QC Date

March 5, 2015

Last Update Submit

April 17, 2024

Conditions

Keywords

brain tumor

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Single saliva or blood sample measuring 10mL for genomic analysis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barrow Neurological Institute at St. Joseph's Hospital Medical Center

Phoenix, Arizona, 85013, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A single saliva or blood sample measuring 10mL for genomic analysis.

MeSH Terms

Conditions

GliomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Peter Nakaji, MD

    Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Operations Manager

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 11, 2015

Study Start

March 1, 2015

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations