Precision Medicine Study - Trial NCT06338150

Timeline & Enrollment

Primary Outcome

Total number of somatic Single-nucleotide variants (SNVs) per patient

Summary

This will be a 2 year study to evaluate and improve cancer sequencing as applied to the
 characterization of tumor molecular make-up and the identification of novel therapeutics
 (n=100). Participants who will undergo tumor biopsy for management of multiple myeloma (MM)
 will self-refer to the study or be referred by their treating physician. Participants will
 initially meet with a clinician to review study consents and provide medical, medication, and
 family history information. After informed consent, biospecimen samples from peripheral
 blood, cheek swab, and tumor samples from bone marrow (aspirate and biopsy), peripheral
 blood, or any mass/fluid containing tumor cells will be obtained (from procedures indicated
 as part of their standard oncology care) for cancer sequencing (CS) (whole exome sequencing
 of germline and tumor genomes, RNA sequencing of tumor transcriptome, single cell, and CyTOF
 analysis). CS data will be interpreted via somatic variation identification, network
 modeling, and cancer transcriptome profiling to facilitate mapping activity levels of genes
 to networks and for identifying genes activated or dysregulated in cancer cells. Sequencing
 and analysis will be performed at the Genomics Core Facility at the Icahn School of Medicine
 at Mount Sinai. In instances where internal sequencing capabilities do not allow for certain
 types of analysis, de-identified samples or data may be sent out to third parties for
 additional analysis. The study will be using GenPath, a division of BioReference® Health, LLC
 for this project which is a CLIA certified lab. All genetic tests will be performed in a CLIA
 certified lab and all tests will be FDA or NYS approved. The RNA Sequencing test will receive
 NYS Department of Health (Wadsworth Center) approval before results are provided to
 physicians and patients. Samples will be de-identified and processed by the Mount Sinai Human
 Immune Monitoring Core (HIMC) before being sent to an external CLIA-certified lab for
 sequencing and analysis. Interpretation will be performed by a multidisciplinary team that
 includes genomicists, pathologists, and clinicians familiar with the particular cancer
 diagnosed in the participant. Once results are available, they will be shared with the
 participant and treating physician during a follow-up results session and any findings
 obtained explained. This study is not intended to implement findings, only to report them.

ICD-10 Classifications