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

Inclusion criteria

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

• Any condition that would make participation in the protocol unreasonably hazardous for the patient in the opinion of the treating physician
• Dementia, altered mental status, or any psychiatric condition or co-morbid condition that would prohibit the understanding or rendering of informed consent.
• The following exclusion criteria apply only to enrolled patients undergoing biopsy for research purposes only:
• History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine) or any medications used for conscious sedation (if applicable).
• Requires general anesthesia for collection of biopsy
• Pregnant or lactating women
• Active cardiac disease
• 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).