Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy
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 single tube of blood 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 experimental cancer treatment.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy|
- frequency of "actionable" oncogenic mutations [ Time Frame: 1 year ] [ Designated as safety issue: No ]"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.
- proportion of patients with an actionable mutation identified [ Time Frame: 1 year ] [ Designated as safety issue: No ]by the research assay (such as IMPACT, WES, WGS) in a gene or hotspot that is not part of the clinical panel performed by the Molecular Diagnostics Service (Sequenom or MiSeq)
- interrogate the mechanisms [ Time Frame: 1 year ] [ Designated as safety issue: No ]underlying response and resistance (de-novo and acquired) to targeted therapy. The research assay(s) used to accomplish this will vary based on the clinical setting and tissue available and may include Sanger, Sequenom, MiSeq, exon-capture (ie: IMPACT), whole exome, and whole genome sequencing.
Biospecimen Retention: Samples With DNA
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Pts with solid tumors
Patients must have solid tumors and be DTC considered a candidate for treatment on a therapeutic clinical trial. Patients must have undergone pathologic confirmation of their tumor at MSKCC and have either: 1) archival tissue available for analysis, 2) have fresh tissue collection planned as routine standard of care outside of the context of this protocol, or 3) prior molecular profiling results. For prospective genotyping tissue specimens from the primary site, a metastasis or recurrence will be used based upon the availability and quality of tissue.
Other: molecular profiling of tumors
The only intervention offered in Part A of this protocol is the molecular profiling of tumors. No new tumor biopsies will be performed in the context of Part A of this protocol. If a pt does have a surgery or tumor biopsy as routine standard of care, leftover tissue 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. Part B: DTC Cohort Pts successfully registered to Part B of this study will be eligible for minimal risk collection & research biopsies. Pts will consent to Part B by signing a separate written informed consent document. Fresh tumor procurement under Part B will be processed & frozen fresh by Tissue Procurement Service (TPS) using standard operating procedures & stored by the Solit laboratory.
|Contact: David Hyman, MD||646-888-4544|
|Contact: David Solit, MD||646-888-2641|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: David Hyman, MD 646-888-4544|
|Contact: David Solit, MD 646-888-2641|
|Principal Investigator: David Hyman, MD|
|Principal Investigator:||David Hyman, MD||Memorial Sloan-Kettering Cancer Center|