Genomic Profiling in Cancer Patients
Summary
The purpose of this study is to determine whether certain genes in cancer may be abnormal. When a gene is abnormal this is called a mutation. Most mutations in cancer cells are not inherited (passed down from parents) but happen after birth in the cancer itself. Most cancers have many mutations. Some of these mutations are important for the cancer cells to survive while others are not. The goal of this study is test cancer for certain mutations using leftover tumor tissue from a previous surgery or biopsy. Participants will also be asked to provide a tube of blood cheek (also known as a buccal) swab, or a saliva sample that contains normal genes for comparison. The purpose of Part B of this study is to: Understand how genetic changes in tumor effect the chance of responding to experimental cancer treatment. Understand how the genes in the tumor change overtime in response to targeted cancer treatment.
Arms & interventions
- Geneticmolecular profiling of tumors
Part A is the molecular profiling of tumors. No new tumor biopsies will be performed in the context of Part A. If a pt does have a surgery or tumor biopsy , leftover tissue (or an additional core) from this procedure may be used for molecular profiling. Clinical Assay(s): This testing will be performed in the CLIA-certified Molecular Diagnostics Service laboratory. Research Assay(s): This protocol will also be used as a platform to pilot the use of investigational "next-generation" profiling technologies .including whole exome sequencing, whole genome sequencing RNA sequencing cell-free tumor DNA/RNA sequencing, proteomics, \& others. To confirm the findings obtained on these assays using an orthogonal assay, additional sequencing such as Sanger,Sequenom, MiSeq or IMPACT testing may be utilized in either the CLIA or non-CLIA setting Part B: DTC Cohort Pts successfully registered to Part B of this study will be eligible for minimal risk collection \& research biopsies.
- GeneticClinical Germline Analysis
Part C: Clinical Germline Analysis Participants who have donated a matched normal peripheral blood sample for comparison to somatic sequence will be offered the opportunity to have that germline DNA sample analyzed for the presence of deleterious or likely deleterious mutations in genes on the MSK-IMPACT panel that are known to be linked to inherited susceptibility or that are included on consensus lists of genes that should undergo secondary analysis (e.g. the "ACMG list"). Part D: Germline Profiling for Individuals at Elevated Cancer Risk
Outcome measures
Primary
frequency of "actionable" oncogenic mutations
"Actionable" mutations will be defined as either 1) a mutation shown to predict for sensitivity or resistance to a drug FDA approved for use in another cancer indication or 2) a mutation which predicts for sensitivity or resistance in preclinical models to an investigational class of drugs.
Time frame: 1 year
Secondary
To determine the impact of molecular profiling results performed in the CLIA-setting on the treatment of patients.
Time frame: 1 year
interrogate the mechanisms
Time frame: 1 year
To explore the genetic mechanisms of tumorigenesis
Time frame: 2
Eligibility criteria
Study locations (18)
St. Vincent (Data Collection Only)
Bridgeport, Connecticut, 06606
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102
Norwalk Hospital
Norwalk, Connecticut, 06850
Baptist Alliance MCI
Miami, Florida, 33143
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Kings County Hopsital Center
Brooklyn, New York, 11203
Memorial Sloan Kettering Cancer Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Metropolitan Hospital Center
New York, New York, 10029
Ralph Lauren Center for Cancer Care and Prevention
New York, New York, 10035
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Medisys Health Network (Data Collection Only)
Richmond Hill, New York, 11418
NYC Health & Hospitals /Lincoln Medical Center
The Bronx, New York, 10451
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
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