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Title Feasibility of Tumor Genomic Sequencing Using the Tempus Platform

IRB CASE6Y16

CC 16-1350

Hospital Main Campus

Disease Solid Tumors

Primary Objective:

To evaluate the feasibility of conducting genomic analyses on tumor tissues using the Tempus platform. Feasibility will be defined as the proportion of patients with a non-failed tumor genomic sequencing report from Tempus within 21 days of received date when all patient samples were delivered to Tempus's Lab ("Received Date").

Secondary Objectives:

To analyze what proportion of genomic analyses yield actionable genetic aberrations, and what proportion lead to change in patient management plan. Actionable will be defined as a mutation linked to an approved therapy in the solid tumor under study or another solid tumor, a known or suspected contraindication to a given therapy, or a clinical trial linked to the alteration.
To evaluate clinical outcomes of specific therapies chosen to target these aberrations. Standard clinical outcome measures (objective response rate, progression-free survival) will be captured.
To describe the germline implications associated with this testing. For patients whose tumor or peripheral blood specimens reveal potentially heritable causes of cancer, leading to the recommendation of further genetic evaluation of patients and/or their blood relatives, we will describe the results of such evaluation. Data gathered under this aim will include referral rate to cancer genetics, completion rate for such referrals, pedigree information, testing referral rates, testing completion rates, and the results of subsequent testing.

Solid tumor with a confirmed histopathologic diagnosis falling into one of the following categories, and without a known curative therapeutic option:
- Metastatic breast cancer
- Metastatic colorectal cancer
- Glioblastoma Metastatic brain tumor
- Metastatic non-small cell lung cancer
Age ≥ 18 years
ECOG performance status 0, 1 or 2
Patient either on active systemic cancer-directed therapy (intravenous or oral chemotherapy, or targeted therapy, or immunotherapy; on- or off-study), or planned to start such therapy within 30 calendar days of enrollment
Prior therapies (e.g. chemotherapy, targeted therapy, surgery, radiation) are permitted but not required
A tissue specimen, from a primary or a metastatic tumor site, obtained within one year prior to the date of informed consent
Consent to have germline testing performed in parallel to tumor testing

Life expectancy of less than 3 months
Patient unwilling to have germline testing performed on peripheral blood 3.0 Study

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