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NCT02688517Recruiting

Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer

Rutgers, The State University of New Jersey

Start Date

2/1/2013

Completion Date

5/1/2030

Summary

This research trial studies the use of targeted genomic analysis of blood and tissue samples from patients with cancer. Genomic sequencing is a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing can be used to find changes in areas of the genome that may be important in the development of cancer. It may also help doctors improve ways to diagnose and treat patients with rare cancers with poor prognosis or lack of effective therapy.

Detailed Description

PRIMARY OBJECTIVES: I. To obtain blood and tumor tissue for next-generation sequencing and determine the frequency of finding genomic alterations for which there are clinically available (commercially or research based) targeted therapies. Treating clinicians will be provided with relevant validated mutation data for treatment or referral of the patient to pertinent studies. II. To collect clinical outcomes of patients with actionable mutations for which sequencing has been performed. III. To obtain tumor genome data for data storage and future computational analysis and correlation with clinical data. IV. To obtain tumor tissue for development of future in vitro and in vivo cancer models. OUTLINE: Previously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. Patients may also undergo collection of blood samples for analysis of circulating cell-free deoxyribonucleic acid (DNA) and circulating tumor cells. After completion of study, patients are followed up every 3 months for 2 years and then every 6 months for 15 years.

Eligibility Criteria

Age Range: 1 years to No maximum

Inclusion Criteria: * Karnofsky/Lansky performance score \>= 30 * A signed written informed consent * Evaluation in surgical/medical/radiation oncology/radiology clinic, with a history of biopsy-confirmed diagnosis of cancer of rare histology and/or poor prognosis with standard therapy; priority will be given to rare cancers with poor prognosis and lack of effective standard therapy; study principal investigator (PI) or designee will review and approve each case before enrollment * Paraffin blocks of the patient's tumor tissue are available and accessible for analysis Exclusion Criteria: * Karnofsky/Lansky performance score \< 30 * Life expectancy \< 3 months

Interventions

OTHER

Cytology Specimen Collection Procedure

OTHER

Laboratory Biomarker Analysis

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Conditions

Malignant Neoplasm

Locations

Ocean Medical Center

Brick, New Jersey 08724

United States

Bayshore Community Hospital

Holmdel, New Jersey 07733

United States

RWJBarnabas Health - Jersey City Medical Center, Jersey City

Jersey City, New Jersey 07302

United States

Southern Ocean County Medical Center

Manahawkin, New Jersey 08050

United States

Morristown Medical Center

Morristown, New Jersey 07960

United States

Jersey Shore Medical Center

Neptune City, New Jersey 07753

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08903

United States

Riverview Medical Center/Booker Cancer Center

Red Bank, New Jersey 07701

United States

Riverview Medical Center

Red Bank, New Jersey 07701

United States

Overlook Hospital

Summit, New Jersey 07902

United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin 53792

United States