Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions

Inclusion Criteria:

1. Current or prospective cancer patients; current cancer patients must have
histologically or cytologically confirmed diagnosis of cancer

2. Tumor tissue available and suitable for molecular analyses from at least one of the
following sources:

- Tissue previously stored in UNC's Tissue Procurement Facility (TPF)

- Tissue previous stored at an institution other than UNC-CH, provided
investigators can determine that the tumors were sampled and stored under
appropriate conditions for inclusion in the study

- Patient undergoing tissue collection as per clinical standard of care and willing
to allow specimens from surplus tissue to be diverted for research purposes

- Patient undergoing tissue collection as per clinical standard of care and willing
to have additional specimens taken for research

- Patient willing to undergo biopsy for purpose of research only

3. The following inclusion criteria apply only to patients undergoing biopsy for research
purposes only under this protocol:

- ≥18 years of age

- Treatment options offer no expectation of cure, e.g., advanced solid tumor
patients with metastatic disease. NOTE: This restriction applies to biopsy of
vital organs only, e.g., lung, liver, etc.

- Appropriate candidate for research biopsy based on institutional standards for
target biopsy site

Exclusion Criteria:

1. Any condition that would make participation in the protocol unreasonably hazardous for
the patient in the opinion of the treating physician

2. Dementia, altered mental status, or any psychiatric condition or co-morbid condition
that would prohibit the understanding or rendering of informed consent.

3. The following exclusion criteria apply only to enrolled patients undergoing biopsy for
research purposes only:

4. History of serious or life-threatening allergic reaction to local anesthetics (i.e.
lidocaine, xylocaine) or any medications used for conscious sedation (if applicable).

5. Requires general anesthesia for collection of biopsy

6. Pregnant or lactating women

7. Active cardiac disease

8. Patients receiving bevacizumab less than 6 weeks prior to enrollment into this study
should not undergo research core biopsies because of the concern for potential
increased bleeding risk and delayed healing. (NOTE: Patients receiving bevacizumab who
are undergoing a research biopsy of accessible organs (e.g. breast, lymph node, skin
etc.) must be two weeks from the last dose of the angiogenesis inhibitor).