IRB Study Number 23-105
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Objective:
- To determine the ability of blood and CSF sampling to detect cfDNA and/or cfRNA in 24 patients with newly discovered, enhancing intracranial lesions of unknown etiology
Secondary Objectives:
To determine which medium (plasma or CSF) contains a higher yield of detectable cfDNA and cfRNA with quantifiable genomic alterations
To determine changes in detectable cfDNA and/or cfRNA during the disease course/treatment
Inclusion Criteria
Patients with new, contrast-enhancing intraparenchymal or meningeal disease with radiographic concern for malignancy for whom brain biopsy or resection, or meningeal biopsy is being performed.
Lack of etiologic diagnosis at time of enrollment
Subjects must have received no prior therapies for this disease.
Age >= 18 years old
Subject or legally authorized representative (if subject does not have capacity) must have the ability to understand and the willingness to sign a written informed consent document for the analysis of CSF and serum. Capacity will be reassessed for the subject to give consent at time of each standard of care follow-up clinic visit, and if criteria are met, the subject will be reconsented at first opportunity.
Subjects must be willing to follow for disease surveillance post-surgery at CCF main campus
Exclusion Criteria
Subjects not eligible to undergo surgery or biopsy for tissue diagnosis
Known etiologic diagnosis at time of enrollment
Subjects for whom disease surveillance post-surgery will not be at CCF main campus
Subjects receiving any other investigational agents.
Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
