Genetic Analysis of Blood and Tissue Samples from Patients with Advanced Cancer, Moonshot Study

Summary

Objectives

PRIMARY OBJECTIVES:
I. To procure paired newly acquired tumor tissues and blood at baseline and upon progression in patients treated for advanced cancer with molecularly targeted therapies at National Cancer Institute Community Oncology Research Program (NCORP) sites.
II. To bank formalin-fixed, paraffin-embedded (FFPE) tissue, blood (for cell-free deoxyribonucleic acid [DNA] analysis), and nucleic acids from patients in the Biorepository, which is the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH), that may be used to study mechanisms of sensitivity and resistance to cancer therapies.
III. To bank, when available, optional snap-frozen tissue (for future to be determined analysis) from patients in the Biorepository, which is the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH), that may be used to study mechanisms of sensitivity and resistance to cancer therapies.
IV. To assess the feasibility of obtaining paired high-quality newly acquired tumor tissues and blood from patients being treated for advanced cancer in community-based healthcare settings (NCORP sites).

SECONDARY OBJECTIVES:
I. To perform molecular profiling assays on matched malignant tumor and blood (including but not limited to whole exome and messenger ribonucleic acid [RNA] sequencing) in order to provide physicians and patients with a clinical report from a Clinical Laboratory Improvement Act (CLIA)-certified laboratory from tumor obtained at baseline and upon progression that may be used to guide further treatment planning.
II. To make available biospecimens for studies to define potential resistance biomarkers using genomic and proteomic-based assessment platforms.
III. To contribute genetic analysis data from coded specimens to Genomic Data Commons, a well annotated cancer molecular and clinical data repository, for current and future research; specimens will be annotated with key clinical data including presentation, diagnosis, staging, summary treatment, and outcome, if possible.
IV. To identify potential predictive and prognostic biomarkers beyond any genomic alteration by which treatment may be assigned.
V. To identify resistance mechanisms using genomic DNA- and RNA-based assessment platforms.

OUTLINE:
Patients undergo collection of blood and tumor prior to starting treatment and upon disease progression (second collection of blood and tumor only for patients who do not continue to progress and achieve either an objective response [OR] or stable disease [SD] after 6 months of treatment). Samples are banked and analyzed via next generation sequencing.