Clinical Biospecimen Collection

Research and development of new diagnostics for earlier detection of, and new treatments for diseases require the use of human biological specimens (biospecimens). Through data and insight gained from the evaluation of these collected biospecimens, the aforementioned novel diagnostics and/or treatments can be developed or validated for a variety of diseases. Biospecimens collected under this protocol may be obtained from subjects with benign conditions, subjects who have been diagnosed with or suspected of having oncological diseases, infectious diseases, auto-immune diseases, endocrine disorders, as well as subjects from healthy normal donors.

The samples and data may be used for genetic research such as: RNA or DNA isolation and analysis, gene and protein expression, diagnostic device and biomarker research, tissue microarray development, laboratory tests and validation tests. The biospecimens may also be used for genome sequencing.

Inclusion criteria

• Subjects must be at least 18 years of age
• Subjects must be deemed competent by a qualified clinical study researcher to provide legally documented informed consent
• Subjects may or may not have active disease at the time of enrollment
• Biospecimens collected under this protocol may be obtained from subjects with benign conditions, subjects who have been diagnosed with or suspected of having oncological diseases, infectious diseases, auto-immune diseases, endocrine disorders, as well as subjects from healthy normal donors.

Exclusion criteria

• Subjects not meeting the inclusion criteria

Additional inclusion and exclusion criteria may exist, specific to individual project plans, for each collection falling under this protocol. These criteria may include genetic mutation status, progression of disease, and prior lines of therapy among others.