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RECRUITING
NCT01775072

Genomic Profiling in Cancer Patients

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2013-01

Completion Date

2027-01

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

GENETIC

molecular 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.

GENETIC

Clinical 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

Locations (18)

St. Vincent (Data Collection Only)

Bridgeport, Connecticut, United States

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Baptist Alliance MCI

Miami, Florida, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Kings County Hopsital Center

Brooklyn, New York, United States

Memorial Sloan Kettering Cancer Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Queens Cancer Center of Queens Hospital

Jamaica, New York, United States

Metropolitan Hospital Center

New York, New York, United States

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Medisys Health Network (Data Collection Only)

Richmond Hill, New York, United States

NYC Health & Hospitals /Lincoln Medical Center

The Bronx, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States