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



Status:Recruiting
Healthy:No
Age Range:1 - Any
Updated:8/11/2018
Start Date:February 2013
End Date:February 2020
Contact:Clinical Trials Office
Phone:732-235-8675

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Targeted Genomic Analysis of Human Cancers

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.

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 whole 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 3 years.

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
We found this trial at
9
sites
Morristown, New Jersey 07962
Principal Investigator: Eric Whitman
Phone: 732-235-8675
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Morristown, NJ
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Brick, New Jersey 08724
Principal Investigator: Mark Krasna
Phone: 732-235-8675
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Brick, NJ
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Holmdel, New Jersey 07733
Principal Investigator: Mark Krasna, MD
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Holmdel, NJ
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Glenn Liu
Phone: 608-265-8689
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Madison, WI
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Manahawkin, New Jersey 08050
Principal Investigator: Mark Krasna
Phone: 732-235-8675
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Manahawkin, NJ
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Neptune, New Jersey 07754
Principal Investigator: Mark Krasna, MD
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Neptune, NJ
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New Brunswick, New Jersey 08903
Principal Investigator: Shridar Ganesan
Phone: 732-235-8675
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New Brunswick, NJ
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Red Bank, New Jersey 07701
Principal Investigator: Mark Krasna
Phone: 732-235-8675
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Red Bank, NJ
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99 Beauvoir Avenue
Summit, New Jersey 07902
(908) 522-2000
Principal Investigator: Eric Whitman
Phone: 732-235-8675
Overlook Hospital Atlantic Health System
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Summit, NJ
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