A Multicenter, Post-Market Follow-up Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study
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.
Time Perspective: Retrospective
To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
Analysis of assay-directed compliance will be conducted immediately after information is collected.
Karl Williams, M.D.
Precision Therapeutics, Inc.
United States: Institutional Review Board
|Winthrop University Hospital||Mineola, New York 11501|
|Cancer Care Northwest||Spokane, Washington 99202|
|North Shore Hematology Oncology||E. Setauket, New York 11733|
|Cancer Care Centers of South Texas||San Antonio, Texas 78229|
|Northwest Cancer Center||Houston, Texas 77042|
|The Regional Cancer Center||Erie, Pennsylvania 16505|
|Oncology Associates of West Kentucky||Paducah, Kentucky 42003|
|Collaborative Research Group||Boynton Beach, Florida 33435|
|Hematology Oncology Associates||Oakland, California 94609|
|Broward Oncology Associates, P.A.||Ft. Lauderdale, Florida 33308|
|Central Baptist Hospital Clinical Research Center||Lexington, Kentucky 40503|
|Cardio-Thoracic Surgeons, P.C.||Birmingham, Alabama 35213|
|The Center For Gynecologic Oncology||Hollywood, Florida 33021|
|Miami International Surgical Services||Miami, Florida 33173|
|GYN Oncology of Miami||Miami, Florida 33143|
|Orlando Cardiovascular Institute PA||Orlando, Florida 32804|
|Edward H. Kaplan, M.D. & Associates||Skokie, Illinois 60076|
|Iowa Clinic||Des Moines, Iowa 50309|
|Grand Blanc Surgical Specialist||Grand Blanc, Michigan 48439|
|Albany Thoracic & Esophageal Surgery||Albany, New York 12208|
|The New York Hospital Medical Center of Queens||Flushing, New York 11355|
|Center for Clinical Research and Technology University Hospitals of Cleveland||Cleveland, Ohio 44106|
|Barry S Siller MD||Houston, Texas 77024|
|Colorectal Surgical Associates||Houston, Texas 77054|
|Heiskell, King, Burns & Tallman Surgical Associates, Inc.||Morgantown, West Virginia 26508|