Laboratory Study of Early Tumor Markers in the Peripheral Blood of Glioblastoma Multiforme Patients
This study is currently recruiting participants.
Verified April 2013 by University of Florida
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01135875
First received: May 24, 2010
Last updated: April 11, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition | Intervention |
|---|---|
|
Glioblastoma Multiforme Controls (Those Without Glioblastoma Multiforme) |
Other: GBM Patients Other: Normal Controls |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Human Glioblastoma Multiforme (GBM) Circulating Tumor Cells (CTCs) as Early, Less Invasive Markers of Progression and Response |
Resource links provided by NLM:
Further study details as provided by University of Florida:
Primary Outcome Measures:
- Identification of Human GBM CD Antigen Signature. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]Already established and stored GBM cell lines will be screened for CD antigens to confirm that a selective cell surface antigen can be identified.
Secondary Outcome Measures:
- Identification & Isolation of Human GBM Cells in Seeded Normal Control Human Blood. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]Frozen and fresh human blood will be seeded with human GBM cells from established stored GBM cell lines and subjected to antibody-based cell identification and isolation procedures.
- Prospective Isolation of GBM Tumor Cells in GBM Patient Blood. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]Circulating tumor cells will be isolated from blood drawn from GBM patients.
- Prospective Evaluation of the Routine Medical History of GBM Patients. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]Medical records of GBM patients will be used to determine how circulating tumor cells impact outcome.
| Estimated Enrollment: | 170 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
GBM Patients
GBM Patients with a histologically confirmed or suspected diagnosis of glioblastoma multiforme.
|
Other: GBM Patients
2 teaspoons of blood will be collected during select clinic visits.
Other Name: 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
2 teaspoons of blood will be collected once.
Other Name: Normal Controls
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Participants will be recruited during routine interactions with the investigators.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135875
Contacts
| Contact: Jennifer West, BSN | 352-273-7981 | jennifer.west@neurosurgery.ufl.edu |
Locations
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Jennifer West, BSN 352-273-7981 jennifer.west@neurosurgery.ufl.edu | |
| Principal Investigator: Erin M Dunbar, MD | |
Sponsors and Collaborators
University of Florida
Investigators
| Principal Investigator: | Erin M Dunbar, MD | University of Florida |
More Information
No publications provided
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01135875 History of Changes |
| Other Study ID Numbers: | CTC-01 |
| Study First Received: | May 24, 2010 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Florida:
|
GBM Brain Tumor Brain Neoplasm |
Control Normal Control Volunteer |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 23, 2013