Prospective Assessment of Correlative Biomarkers in CNS Patients (The PROACTIVE Program) - A biomarker-driven program for clinical trial development for newly diagnosed and recurrent CNS patients
The goal of this clinical research study is to collect blood and tumor tissues for biomarker testing from patients with brain tumor. Biomarkers are found in the blood and tissues and may be related to the body's reaction to the disease and/or treatment. Researchers will use these biomarkers to look for and understand factors that may play a role in the development of brain tumor. Researchers also want to learn about possible genetic changes that may be related to brain tumor. Some of these biomarkers may be used for diagnosis and patient care (or may be used to discuss treatment options).
Disease Group: Brain,CNS
Treatment Agent: None
Treatment Location: Only at MD Anderson
1. Primary Objective: To determine the rate of successful biomarker collection on all CNS tumor patients. 2. Secondary Objectives: Determine the progression free (PFS) and overall survival (OS) of enrolled patients compared to historical controls from the published literature. Compare radiographic response rates (RR) and PFS rates to historical controls. To measure and correlate biomarkers from biospecimens with patient outcomes. To determine putative predictive biomarkers of response to specific therapies for developing clinical trials and rational enrollment into future clinical trials. Qualitatively assess patient reported outcomes data on all patients before, during, and after treatment. Quantitatively assess neurocognitive function data on all patients before, during, and after treatment. Correlate molecular biomarkers, patient reported outcomes and neurocognitive outcomes before, during and after treatment. Correlate quantitative and qualitative imaging biomarkers with molecular and genomic characteristics to develop predictive models of response and progression.
IRB Review and Approval Date: 08/23/2012
Recruitment Status: Open
Projected Accrual: N/A
1) Patient with a radiographically suspected new or recurrent CNS malignancy.
2) Age >/= 18 years.
3) Karnofsky Performance Status (KPS) >/= 60.
4) The patient, family member or guardian has signed informed consent.
1) Patient unable to comply with study procedures for any reason.
2) Patient, family member or guardian is unable to provide informed consent.
Phone Number: 800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
clinicaltrials.gov NCT No: Not Applicable Clinical Trial
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