Evaluation of Pathwork Tissue of Origin (TOO) Test for Human Malignancies

• To determine the fraction of TOO test results that are "indeterminate"
• To assess the fraction of "Clinical Truth" determinations that is "off panel" (i.e. not one of the 15 tissues of origin tested for in the TOO test
• To determine the fraction of TOO tests that leads to additional confirmatory diagnostic testing, or alters the final clinical diagnosis and/or clinical management
• To determine the fraction of samples submitted for TOO testing in which the standard of care cannot determine a tissue of origin (unknown primary cancers)

The pathworks tissue of origin test is a microarray-based test with the goal of identifying the tissue of origin in patients with metastatic tumors of unknown primary site.

Patients with a diagnosis of malignancy

Inclusion Criteria:1 Subjects must be at least 18 years old. The TOO test is designed to determine the tissue of origin of common adult malignancies. There are no gender/ethnic restrictions.

2 Patients with a diagnosis of malignancy established by pathologic review of H&E staining of tumor biopsy or tumor resection without definitive determination of tissue of origin as assessed by the PI. Samples must have been obtained within three months of enrollment, or the patient must still be under active evaluation for tissue of origin at the time of enrollment. There are no limitations on prior therapy and time from last prior therapy.

3 Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:1 Patients under the age of 18 are excluded. There are no exclusions based on gender/ethnicity.

2 There are no exclusion requirements due to co-morbid disease or incurrent illness, as needed.

3 Pregnancy or nursing participants will not be excluded from the study.

4 Patients with a diagnosis of leukemia including acute myelogenous leukemia, acute lymphocytic leukemia, hairy cell leukemia, chronic myelogenous leukemia and chronic lymphocytic leukemia are excluded from enrollment on this study. The TOO test does not cover these diagnoses.