NCT01135875

Brief Summary

The purpose of this study is to determine if tumor cells can be detected in the blood of patients diagnosed with a brain tumor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 17, 2013

Status Verified

October 1, 2013

Enrollment Period

3.5 years

First QC Date

May 24, 2010

Last Update Submit

October 15, 2013

Conditions

Keywords

GBMBrain TumorBrain NeoplasmControlNormal ControlVolunteer

Outcome Measures

Primary Outcomes (1)

  • Identification of Human GBM CD Antigen Signature.

    Already established and stored GBM cell lines will be screened for CD antigens to confirm that a selective cell surface antigen can be identified.

    3 Years

Secondary Outcomes (3)

  • Identification & Isolation of Human GBM Cells in Seeded Normal Control Human Blood.

    3 Years

  • Prospective Isolation of GBM Tumor Cells in GBM Patient Blood.

    3 Years

  • Prospective Evaluation of the Routine Medical History of GBM Patients.

    3 Years

Study Arms (2)

GBM Patients

GBM Patients with a histologically confirmed or suspected diagnosis of glioblastoma multiforme.

Other: GBM Patients

Normal Controls

Normal Controls will be adult volunteers who identify themselves as not having been diagnosed with a glioblastoma multiforme.

Other: Normal Controls

Interventions

2 teaspoons of blood will be collected during select clinic visits.

GBM Patients

2 teaspoons of blood will be collected once.

Normal Controls

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited during routine interactions with the investigators.

You may qualify if:

  • to 89 years of age
  • Weight of at least 110 pounds
  • Able to provide informed consent for self

You may not qualify if:

  • Patients with active malignant tumors other than GBM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

GlioblastomaBrain Neoplasms

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, 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

  • Brent Reynolds, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2010

First Posted

June 3, 2010

Study Start

October 1, 2009

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 17, 2013

Record last verified: 2013-10

Locations