ChemoFx® PRO - A Post-Market Data Collection Study



Status:Recruiting
Conditions:Lung Cancer, Colorectal Cancer, Ovarian Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Women's Studies, Endometrial Cancer
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:October 2006
Contact:Lauren Stein
Email:registry@ptilabs.com
Phone:(412) 432-1350

Use our guide to learn which trials are right for you!

ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes


This study will collect patient demographic, oncology history, and physician reported
outcome information following the initial round of chemotherapy received after a commercial
ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for
further sub-studies.


The traditional treatment course for new cases of many cancers is cytoreductive surgery
followed by chemotherapy. Unfortunately, despite high initial response rates to treatment,
the majority of patients recur. The use of ineffective chemotherapy can result in
unnecessary toxicity and costs, delay of more effective treatment, and the potential for the
development of cross-resistance to additional drugs. The ability to individualize therapy by
providing the treating physician with ex vivo response information on a panel of drugs
should aid in the selection of effective therapy for individual patients, thus resulting in
improved outcomes.

ChemoFx® is a drug response marker that quantifies an individual cancer patient's probable
tumor response to various chemotherapeutic and biologic agents—providing both sensitivity
and resistance information. In a retrospective study, it was demonstrated that patients
treated with a regimen that the ChemoFx® test said the patients' cells would be sensitive
to, corresponded to a 3 times longer progression free interval.

In the PT-206 ChemoFx PRO® study, patients will be followed through treatment, until the
patient progresses or a significant change in chemotherapy occurs. This data will be
collected and analyzed to identify potential patient cohorts for the development of
hypotheses for future sub-study analysis. Also, tumor pathology slides and excess tumor
cells (if available) will be used to characterize common polymorphisms in drug metabolizing
enzymes as well as other molecular markers potentially associated with tumor response.

The PT-206 ChemoFx PRO® Study seeks to enroll an estimated 3,000 patients from 150 academic
and community-based physicians in the U.S. The patients will be treated with drugs and/or
drug combinations based on the medical judgment of the treating physician. This study is not
randomized.

Inclusion Criteria:

- Patient has been diagnosed with a solid tumor malignancy and their physician has
received a final report for ChemoFx® after August 1, 2006

- Chemotherapy must be clinically indicated for treatment of the patient's qualifying
disease

- Patient must be at least 18 years of age

- Patient must have signed an IRB approved informed consent form for the data
collection study prior to entry of data into the enrollment form in the database.

Exclusion Criteria:

- Patient pathology shows benign pathology for sample submitted

- Patient is not indicated to receive chemotherapy for their disease
We found this trial at
67
sites
Baltimore, Maryland 21215
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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Fort Myers, Florida 33901
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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Fort Sam Houston, TX
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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533 Parnassus Ave
San Francisco, California 94122
(415) 476-9000
University of California - San Francisco The leading university exclusively focused on health, UC San...
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1309 North Flagler Drive
West Palm Beach, Florida
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Albany, New York 12208
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Annandale, Virginia 22003
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Asheville, North Carolina 28806
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Atlantic Beach, New York 11509
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Charleston, South Carolina 29403
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Charlotte, North Carolina 28233
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Charlotte, North Carolina 28204
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Chattanooga, Tennessee 37403
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Chattanooga, Tennessee 37403
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Chicago, Illinois 60612
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Clearwater, Florida 33756
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Coconut Creek, Florida 33073
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Columbus, Ohio 43026
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Covington, Louisiana 70433
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Dallas, Texas 75251
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Delray Beach, Florida 33444
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Evanston, Illinois 60201
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Fort Lauderdale, Florida 33308
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Franklin Twp, New Jersey 08043
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Grand Rapids, Michigan 49546
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Hartford, Connecticut 06102
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Jackson, Mississippi 39216
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Knoxville, Tennessee 37922
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Manhassett, New York 11030
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307 N University Blvd
Mobile, Alabama 36688
(251) 460-6101
University of South Alabama "University of South Alabama is a public institution that was founded...
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Morgantown, West Virginia 26505
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Morristown, New Jersey 07962
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Neptune, New Jersey 07754
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New York, New York 10038
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Oklahoma City, Oklahoma 73112
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Pembroke Pines, Florida 33028
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Pittsburgh, Pennsylvania 15212
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4800 Friendship Ave
Pittsburgh, Pennsylvania 15224
(412) 578-5000
Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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101 Dudley St
Providence, Rhode Island 02905
(401) 274-1100
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
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Riverdale, Georgia 30274
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Roanoke, Virginia 24016
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Rockville, Maryland 20852
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San Antonio, Texas 78258
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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4700 Waters Ave
Savannah, Georgia 31404
(912) 350-8000
Memorial Health University Medical Center Memorial University Medical Center (MUMC) is a nonprofit, 622-bed tertiary...
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Sherman Oaks, California 91403
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Shreveport, Louisiana 71101
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Sioux Falls, South Dakota 57105
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South Miami, Florida 33143
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Teaneck, New Jersey 07066
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Torrance, California 91403
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West Allis, Wisconsin 53227
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Wilmington, North Carolina 28402
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Worcester, Massachusetts 01605
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