Pancreatic Cancer Clinical Trial
Official title:
Quantitative Targeted Proteomics Detected by Mass Spectrometry With Whole Genome (DNA) and Whole Transcriptome (RNA) Sequencing in Advanced Cancers
Among patients with advanced (metastatic) cancers, detailed characterizations of the tumor utilizing genomic and proteonomic techniques may help guide treatment. It, however, remains unclear if these new diagnostic technologies truly influence clinical and economic outcomes. This study will evaluate if patients treated according to the results of the NantHealth GPS Cancer test achieve optimal outcomes compared to patients whose treatment are discordant with GPS Cancer recommendations.
Personalized Medicine approaches to cancer management require detailed diagnostic
evaluations. Broad genomic profiling,using whole genome (DNA) and whole transcriptome(RNA)
sequencing platforms,holds the promise of identifying tumor related mutations that are
amenable to targeted therapies, with the potential for improved clinical outcomes and lower
toxicities compared to traditional cytotoxic chemotherapy. Proteomic approaches may add
additional insights into treatment selection by identifying protein biomarkers known to
induce drug resistance or indicate drug sensitivity for chemotherapy, monoclonal antibody
therapy, hormonal therapy, targeted therapy and immunotherapy. The full value of these
approaches has not been realized in routine clinical cancer care.
GPS Cancer™ is a comprehensive test available through NantHealth. GPS Cancer which integrates
whole genome (DNA) sequencing, whole transcriptome (RNA) sequencing, and quantitative
proteomics through mass spectrometry, provides oncologists with a comprehensive molecular
profile of a patient's cancer to inform personalized treatment strategies. GPS Cancer testing
is conducted in CLIA-certified and CAP-accredited laboratories.
Hypothesis:
1. The addition of proteomics to next generation sequencing (NGS) via the NantHealthGPS
Cancer test and the incorporation of whole genome sequencing will identify treatment
algorithms with increased likelihood of successful clinical outcomes in patients with
advanced cancers.
Study Design(summary):
1. The patient population will consist of 160 total individuals with tumor tissue available
for NantHealth GPS Cancer testing: (1) pancreatic cancer patients ineligible for
curative surgery, (2) metastatic breast cancer, (3) advanced stage
(non-resectable/metastatic/incurable) lung cancer, (4) metastatic non-resectable
malignant melanoma, (4) metastatic colon cancer not amenable to curative therapy, and
(5) metastatic hormone refractory prostate cancer.
2. The treating oncologists will declare any planned treatment strategies before the
testing results are obtained.These plans will be compared retrospectively with the
actual treatment plans delivered to the patient to determine the "change rate".
3. The executive steering committee will review the NantHealthGPS Cancer reports and
compare the results against the actual delivered therapy. Patients will be segregated
into cohorts of "GPS treatment concordant" and "GPS treatment discordant".
4. A cohort of patients with similar diseases(matched via the COTA Nodal Address system)
will be drawn at a ratio of 3 to 1 from the COTA database.
5. The time on chosen therapy (time to treatment failure) will be calculated for the cohort
of patients with "GPS treatment concordant", "GPS treatment discordant", and "matched
controls". The times will be compared using standard statistical analyses.
6. The total cost of care for the three treatment cohorts will also be compared.
7. Subjects must possess medical insurance coverage from Horizon Blue Cross Blue Shield of
New Jersey in order to participate. A maximum of 160 patient samples will be tested.
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