Liquid Biopsy-informed Precision Oncology Study to Evaluate the Clinical Utility of Non-invasive Comprehensive Genomic Profiling for Cancer Treatment Selection
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
Overall, this project has three main goals: first, to ascertain the feasibility of the approach and identify whether liquid biopsies can detect actionable mutations that can be utilized to generate precision oncology treatment recommendations. Second, the investigators will investigate whether enacting upon MTB recommendations would improve outcomes in terms of progression-free and overall survival. Third, the investigators aim to determine if molecular profiling via serial plasma tests after initiation of chemotherapy or other targeted treatment is sufficient to determine whether or not a patient is responding to therapy.
Description
1. Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing. All information will be collected on study-specific case report forms (CRFs) hosted in Redcap and/or directly entered into a study database. The following measures will be taken to protect patient information: * The database will be password protected; only authorized staff may enter and view project data. * Passwords and system IDs will not be shared. * Physical security of the workstations/files will be maintained. Workstations with the database…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
Inclusion Criteria: * ECOG performance status of 0-1. * Patients with solid tumors, including esophageal cancer, non-adenocarcinoma NSCLC, small-cell lung cancer, head \& neck cancer, mesothelioma, breast cancer and lung neuroendocrine cancer. * Patients who can provide whole blood collection to meet minimum of 20-30ml of blood at baseline, within 1-3 weeks from treatment initiation, at first radiographic imaging and at progression. Acquisition of an archival or time-matched tumor tissue specimen which meets the minimum sample input requirements (at least 20% tumor content and 100 ng) is pref…
Interventions
- OtherNon-invasive Comprehensive Genomic Profiling for Cancer Treatment Selection
Use of liquid biopsy to evaluate the clinical utility of non-invasive comprehensive genomic profiling for cancer treatment selection.
Location
- Johns Hopkins UniversityBaltimore, Maryland