Tumor tissue often can be “identified,” meaning that the hospital or research center is able to link the information derived from the material to the specific patient. In such cases, researchers can access information about the patient’s diagnosis, treatments, and outcome.

Tissue samples may also be “de-identified,” meaning that they are provided to researchers without any information that could identify the tissue donor, consistent with HIPAA regulatory procedures. HIPAA refers to the Health Insurance Portability and Accountability Act, which includes provisions concerning the security and privacy of health data.)

Linking Patient Tumors with State Cancer Registries

Some research takes place without patients’ knowledge. Once a pathologist’s analysis of a tissue specimen is completed and a cancer diagnosis has been made, the anatomic pathology laboratory information system (LIS) transmits the diagnosis, which is a “reportable event,” to the hospital cancer registry and the state cancer registry. The state cancer registry creates a record of the patient’s cancer in the cancer registry record.

Established by Congress through the Cancer Registries Amendment Act in 1992 and administered by the Centers for Disease Control and Prevention (CDC), the National Program of Cancer Registries (NPCR) collects data on the occurrence of cancer, the type, extent, and location of the cancer, and the type of initial treatment.