A Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:November 2010
End Date:October 2017
Contact:Darrell Lis, MSN
Email:PT207@ptilabs.com
Phone:877-628-8472

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A Multicenter, Post-Market Follow-up Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study


The purpose of this research study is to collect information from patient's medical records
that had a test called ChemoFx® ordered and to understand how doctors may have used the
results of the ChemoFx® to treat patients with cancer.


While studies support the clinical use of ChemoFx® in cancer patients, additional data are
needed to further assess the utilization of this product in clinical practice. Such
post-market data and information could be employed for product improvement as well as for
the development of standards and regulations. This is a multicenter registry study of 3,000
patients with solid tumors. The study is not randomized, nor is it interventional in that
the treating physician is free to choose how to employ ChemoFx® results in the clinical
management of individual patients. Sites will be selected by Precision's clinical trials
team based on past commercial usage of ChemoFx®.

Subjects who may be enrolled in this study are those who have been diagnosed with a solid
tumor malignancy and for whom ChemoFx® has been ordered. ChemoFx® is ordered through the
normal commercial process and is therefore billed to the patient's medical insurance.

All subjects will be appropriately consented before any study-specific data are collected. A
limited dataset of patient demographics, oncology history, and therapeutic intervention will
be collected in addition to ChemoFx® assay usage. Subjects will be treated based on the
medical judgment of their treating physician(s). Patient survival data will be collected up
to five years following the ChemoFx® commercial order. Additional disease progression data
may be collected by Precision's CRAs at participating sites.

Optional Cell Research

Informed consent will be obtained to document subject's consent to use excess cells
remaining in Precisions' commercial laboratory for additional research. This portion of the
study may involve DNA, RNA, and proteomic research. To ensure the anonymity of each subject,
any identifiers that would link the sample to the subject will be removed. The samples would
then have gene expression profiling and or quantitative protein expression analysis
performed. The goal of the research would be to identify a set of informative genes,
intermediaries, and proteins and develop predictive algorithm(s) that seek to link the
expression level of the gene, gene signature, intermediary, or protein to the clinical
outcome of the patient. This portion of the study does not require any additional subject
procedures. Neither physicians nor their patients will receive the results of the research
performed. Results will not be placed in the subjects health care records and will not
affect their medical care.

Inclusion Criteria:

- Pathologically confirmed diagnosis of solid tumor malignancy;

- Medically indicated to receive chemotherapy;

- Fresh tissue submitted from the solid tumor malignancy for testing with the ChemoFx®
assay after August, 2006;

- Final ChemoFx® assay report is available;

- Subject must be at least 18 years of age;

- Subject must sign and date an IRB approved ICF.

Exclusion Criteria:

- Enrolled in PT-103, PT-106, PT-206, PT-301, or PT-304;

- Pregnant or lactating subjects;

- Subjects are not indicated to receive chemotherapy for their disease;

- Subjects with psychiatric or addictive disorders that would preclude obtaining
informed consent.
We found this trial at
28
sites
Skokie, Illinois 60076
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6405 N Federal Hwy # 300
Fort Lauderdale, Florida 33308
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Albany, New York 12208
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Birmingham, Alabama 35213
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Boynton Beach, Florida 33435
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Cleveland, OH
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Des Moines, Iowa 50266
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Des Moines, IA
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East Setauket, New York 11733
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Erie, Pennsylvania 16505
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Erie, PA
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Flushing, NY
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Grand Blanc, Michigan 48439
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Grand Blanc, MI
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Greenwood, MS
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Hollywood, Florida 33021
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Hollywood, FL
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Houston, Texas 77090
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Houston, TX
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Houston, Texas 77024
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Houston, TX
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Houston, Texas 77054
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Houston, TX
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Lexington, KY
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Miami, FL
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Miami, Florida 33143
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Miami, FL
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Mineola, NY
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Morgantown, WV
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Oakland, California 94609
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Oakland, CA
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Orlando, Florida 32804
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Orlando, FL
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Paducah, Kentucky 42003
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100 NE Loop 410; Suite 600
San Antonio, Texas 78216
210-424-1600
Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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San Antonio, TX
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Spokane, Washington 99218
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Spokane, WA
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Staten Island, New York 10310
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Staten Island, NY
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Syracuse, New York 13057
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Syracuse, NY
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