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

18 Years
Not Enrolling
Solid Organ Tumors

Thank you

Trial Information

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.

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.

Type of Study:


Study Design:

Time Perspective: Retrospective

Outcome Measure:

To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.

Outcome Time Frame:

Analysis of assay-directed compliance will be conducted immediately after information is collected.

Safety Issue:


Principal Investigator

Karl Williams, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Precision Therapeutics, Inc.


United States: Institutional Review Board

Study ID:




Start Date:

November 2010

Completion Date:

October 2012

Related Keywords:

  • Solid Organ Tumors
  • Ovarian
  • Fallopian Tube
  • Peritoneal
  • Uterine Neoplasms
  • Vulva
  • Endometrial
  • Cervical
  • Lung
  • Carcinoid
  • Sarcoma
  • Mesothelioma
  • Adenocarcinoma
  • Colorectal
  • Breast
  • Assay
  • Chemotherapy
  • Recurrent
  • Refractory
  • Persistent
  • Chemoresponse



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