protocolSection identificationModule nctId: NCT06338150, orgStudyIdInfo id: STUDY-23-00503, secondaryIdInfos id: GCO 19-0175, type: OTHER_GRANT, domain: Icahn School of Medicine at Mount Sinai, secondaryIdInfos id: 5R01CA244899, type: NIH, link: https://reporter.nih.gov/quickSearch/5R01CA244899, briefTitle: Precision Medicine Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: 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., conditionsModule conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Total number of somatic Single-nucleotide variants (SNVs) per patient, secondaryOutcomes measure: Total number of somatic insertions (INS) per patient, secondaryOutcomes measure: Total number of somatic deletions (DEL) per patient, secondaryOutcomes measure: Number of SNVs per megabase of the MM genome, secondaryOutcomes measure: Number of INS per megabase of the MM genome, secondaryOutcomes measure: Number of DEL per megabase of the MM genome, secondaryOutcomes measure: Number of mutations per megabase among MM subgroups, secondaryOutcomes measure: Number of mutations per megabase among genomic regions for all MM and mutational subgroups, secondaryOutcomes measure: Gene mutations identified, secondaryOutcomes measure: Chromosomal abnormalities identified, secondaryOutcomes measure: Molecular signatures identified, secondaryOutcomes measure: Established Prognostic markers identified, secondaryOutcomes measure: Somatic variants identified as targets of FDA-approved drugs (pharmacogenomics variant data), secondaryOutcomes measure: Network-informed key driver variants identified, secondaryOutcomes measure: Transcriptome variations identified, secondaryOutcomes measure: Germline mutations identified in cancer predisposition genes, secondaryOutcomes measure: FDA approved drugs available that block enzymes produced in those pathways identified, secondaryOutcomes measure: Treatment recommended by computational pipeline based on patient's clinical and genetic, secondaryOutcomes measure: Germline whole exome sequencing profile, secondaryOutcomes measure: Tumor genome whole exome sequencing profile, secondaryOutcomes measure: Tumor transcriptome profile, secondaryOutcomes measure: Single-cell sequencing profile, secondaryOutcomes measure: Cytometric profile, secondaryOutcomes measure: Signaling Pathways associated, secondaryOutcomes measure: Enzymes associated with each signaling pathway identified, secondaryOutcomes measure: Improvement of cancer sequencing-guided treatment recommendations by machine learning, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai Health System, city: New York, state: New York, zip: 10029, country: United States, contacts name: Cesar Rodriguez Valdes, MD, PhD, role: CONTACT, email: Cesar.Rodriguez@mssm.edu, contacts name: Katherine Vandris, role: CONTACT, email: Katherine.Vandris@mssm.edu, contacts name: Cesar Rodriguez Valdes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False