Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer

PRIMARY OBJECTIVES:

I. To obtain blood and tumor tissue for next-generation sequencing and determine the
frequency of finding genomic alterations for which there are clinically available
(commercially or research based) targeted therapies. Treating clinicians will be provided
with relevant validated mutation data for treatment or referral of the patient to pertinent
studies.

II. To collect clinical outcomes of patients with actionable mutations for which sequencing
has been performed.

III. To obtain whole tumor genome data for data storage and future computational analysis and
correlation with clinical data.

IV. To obtain tumor tissue for development of future in vitro and in vivo cancer models.

OUTLINE:

Previously collected tissue samples are analyzed for the presence of mutations via next
generation sequencing. Patients may also undergo collection of blood samples for analysis of
circulating cell-free deoxyribonucleic acid (DNA) and circulating tumor cells.

After completion of study, patients are followed up every 3 months for 2 years and then every
6 months for 3 years.

Inclusion Criteria:

- Karnofsky/Lansky performance score >= 30

- A signed written informed consent

- Evaluation in surgical/medical/radiation oncology/radiology clinic, with a history of
biopsy-confirmed diagnosis of cancer of rare histology and/or poor prognosis with
standard therapy; priority will be given to rare cancers with poor prognosis and lack
of effective standard therapy; study principal investigator (PI) or designee will
review and approve each case before enrollment

- Paraffin blocks of the patient's tumor tissue are available and accessible for
analysis

Exclusion Criteria:

- Karnofsky/Lansky performance score < 30

- Life expectancy < 3 months