Major considerations in biospecimen collection and handling reported by the Society for Immunotherapy of Cancer Surgery Committee
| Prior to biopsy | During collection | After collection | Therapeutic immune cell collection |
| Early consultation with surgical or interventional physician expertise | Ensure that all supplies and collection containers are available | Ensure rapid delivery to laboratory, if appropriate | Sterile conditions must be used throughout |
| Early consultation with surgical pathologist to plan specimen allocation and testing (ie, SOC vs research) | Once tissue is obtained, processing should be as rapid as possible | Rapid shipping with proper labels and addresses | Ensure all processing and shipping SOPs are in place |
| Ensure IRB approval and written informed consent are obtained prior to the procedure | Ensure enough tissue is obtained, especially if required for SOC | Monitor the temperature of collected specimens prior to processing and avoid excessive heat | Work with clinical immunotherapy experts to ensure appropriate patients and lesions are selected |
| Establish SOPs for specimen collection at institution | If sample not fixed immediately, consider vacuum sealing, placing in sterile gauze with preservative fluid, or on ice in sterile system | If processing is delayed, keep specimen on ice unless otherwise indicated | Confirm days and times open for specimen receiving prior to procedure |
| Ensure that all personnel involved in tissue collection are trained in local SOPs | If a biosafety cabinet is not available, establish a “clean” area for initial specimen handling | ||
| Consider the number of cells and viability status needed from tissue; consult with immunology experts to define | Avoid contact between different specimens | ||
| Consider preservatives needed to process and store tissue once collected | Use new supplies and containers for each new specimen | ||
| Consider if matched specimens are needed (ie, PBMC and tumor) at each time point | |||
| Determine the type of biopsy (eg, core needle, incisional, excisional, etc.) to be done and what instruments and reagents (eg, needles, collection bottles, preservatives, etc.) are needed | |||
| Understand institutional policies and regulations, including coordination with pathology for SOC | |||
| Ensure pre-labeling of all specimen containers and patient materials | |||
| Consider using a time tracking process with documentation | |||
| Consider collecting normal tissues as control |
IRB, institutional review board; PBMC, peripheral blood mononuclear cell; SOC, standard of care; SOP, standard operating procedure.