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Laboratory Study of Early Tumor Markers in the Peripheral Blood of Glioblastoma Multiforme Patients

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 89 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Patients with active malignant tumors other than GBM

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01135875
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Florida
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Brent Reynolds, PhD
Principal Investigator Affiliation University of Florida
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme, Healthy Volunteers
Additional Details

Despite aggressive therapies, Glioblastoma Multiforme (GBM) is rapidly fatal. GBMs are increasingly recognized for occasionally metastasizing through the peripheral blood to distant locations. This research study involves the detection and novel characterization of human GBM (hGBM) circulating tumor cells (CTCs) within the peripheral blood of brain tumor patients by identifying their unique cell surface antigen profile, determining an optimal isolation protocol, and quantitatively and qualitatively reporting the yield and characteristics.

Arms & Interventions

Arms

: GBM Patients

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

: Normal Controls

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

Interventions

Other: - GBM Patients

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

Other: - Normal Controls

2 teaspoons of blood will be collected once.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Florida, Gainesville, Florida

Status

Address

University of Florida

Gainesville, Florida, 32610