Details

Details

Title Identifying and overcoming barriers to precision oncology among racial and ethnic minorities

IRB CASE 2Y15

CC 15-796

Hospital Main Campus, South Pointe

Disease All Cancer Types

Description

Description

  1. To examine attitudes among cancer patients toward participation in precision oncology screening and clinical trials. We will use survey-based methodology in consecutive racial minority patients presenting for cancer care at South Pointe to define these attitudes.
  2. To identify and remove barriers to access to novel oncology therapeutics in an underserved population. A stepwise approach to identify, understand, and mitigate barriers to access to precision oncology will be evaluated.
    • To describe the prevalence of actionable alterations in tumors obtained from racial and ethnic minority patients. Tumor samples from patients with common solid tumors will be sequenced for genomic alterations and results will be compared with a similar cohort from a heterogeneous clinic population (via CASE1Y13).
    • To identify barriers to access to targeted therapies available for on-label, off-label, or on-clinical trial use in patients with previously identified biologically actionable alterations. We will focus on the subgroup of patients identified through Objective 2.1 with recommendations for targeted therapies. We will compare access rates to a subgroup of Caucasian patients in the previously described research study at Main Campus.
    • To reduce barriers to access to targeted therapies by utilizing a patient navigation program. We will focus on subgroups of cohorts identified in 2.2 with barriers to access to novel therapeutics. We will utilize a patient-centered navigation program based primarily at South Pointe to remove identified barriers to access.
Inclusion Criteria

Inclusion Criteria

a) Solid tumor with a confirmed histopathologic diagnosis falling into one of the following categories and without a known curative therapeutic option:

i) Metastatic/locally-advanced non-small cell lung cancer

ii) Metastatic breast cancer: either triple-negative – defined as ER-negative (<1%), PR-negative (<1%), HER2 non-amplified (IHC 0/1 or FISH ratio <2.0) at any line of therapy; or hormone receptor positive/HER2 negative that are endocrine therapy and/or chemotherapy resistant (progressed on more than 2 lines of endocrine therapy and/or more than 2 chemotherapy regimens in the metastatic setting)

iii) Metastatic colorectal cancer

iv) Metastatic castration-resistant prostate cancer

b) Age ≥ 18 years

c) Self-reported race/ethnicity as any other than non-Hispanic White/Caucasian

d) ECOG performance status 0, 1 or 2

e) Measurable and/or evaluable disease per RECIST version 1.1

f) Prior therapies (e.g. chemotherapy, targeted therapy, surgery, radiation) are permitted

Exclusion Criteria

Exclusion Criteria

  • Existing tumor genomic profile by a next-generation sequencing platform