Measuring enzymes (protein molecules) (Cytochrome C Oxidase Activity) in newly diagnosed brain cancer

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"Can the amount of enzymes in brain cancer (glioblastoma multiform) help predict overall survival and disease progression?"
Age:
21 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
Brain cancer, cancer
Type:
Observational
Investigator:
Description
This study measures amount of enzymes (protein molecules) that may be present in tumor specimens from patients with newly diagnosed primary brain cancer.
This study requires
Sample of tumor tissue removed during your surgery. Small research samples will
be taken during surgery and frozen.

We will not use this sample for research until all of the
usual diagnostic studies are completed.

Obtain information on your health, medications, brain scans (MRIs) and progress so that we
can compare information we obtain from your tumor tissue with how you are doing.
Who can participate?
Inclusion Criteria

Pre-Surgery:

1. Willingness and ability to provide written informed consent and to comply with the study protocol as judged by Physician interview (NOTE: This could be patient's Neurosurgeon, Neuro-Oncologist or Study Investigator).

2. Age ≥ 21years

3. Karnofsky Performance Status (KPS) ≥ 60.

4. Subjects' planned upfront treatment to be SOC with Radiotherapy and Temozolomide (i.e. TEMODAR) for histologically confirmed GBM at initial diagnosis

5. No history of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years.

6. No serious active infection (e.g., wound infection requiring parenteral antibiotics) or other serious underlying medical conditions that in the opinion of the investigator would compromise standard of care treatment.

7. No other condition (e.g., psychological or geographical) that would preclude study compliance.

8. An MRI that is consistent with a primary malignant glioma

Post-Surgery:

9. Histologically confirmed newly diagnosed Primary GBM before treatment using World Health Organization (WHO) classification criteria (A local pathology report constitutes adequate documentation of histology for initial study enrollment, however central pathology review will be required to confirm the diagnosis of GBM for final data analysis).

10. Availability of tumor tissue representative of GBM > 70 mg, snap-frozen within 30 minutes of resection, 10 minutes or less at room temperature.

11. All subjects must have received maximal safe resection followed by standard radiation therapy with concomitant Temozolomide taken during the course of radiation therapy.


Exclusion Criteria:

1. Inability to fulfill the requirements of the protocol

2. Any severe post-operative infection or other complications that may significantly delay the initiation of brain tumor therapy, or other conditions that, in the opinion of the investigator, would compromise the subject's ability to participate in the study.

3. Secondary GBM or other gliomas.

4. History of sensitivity to Temozolomide.

5. Planned upfront treatment with any anti-angiogenic agent targeting the (vascular endothelial growth factor (VEGF) pathway including but not limited to bevacizumab, cediranib, vandetanib, sunitinib, pazopanib, aflibercept, or sorafenib or any immunotherapy regimen.

6. GLIADEL wafers in combination with surgical resection.
Resources
Schedule
Study duration and period
No visits Periodic phone calls up to 2 years
Recruitment period
From Feb. 10, 2017
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Primary Glioblastoma Multiforme

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