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

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.

Study Overview

• Status: Terminated
• Conditions: Solid Organ Tumors

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 167

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Cardio-Thoracic Surgeons, P.C.
  • California
    • Oakland, California, United States, 94609
      • Hematology Oncology Associates
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Collaborative Research Group
    • Fort Lauderdale, Florida, United States, 33308
      • Broward Oncology Associates, P.A.
    • Hollywood, Florida, United States, 33021
      • The Center For Gynecologic Oncology
    • Miami, Florida, United States, 33143
      • GYN Oncology of Miami
    • Miami, Florida, United States, 33173
      • Miami International Surgical Services
    • Orlando, Florida, United States, 32804
      • Orlando Cardiovascular Institute PA
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Edward H. Kaplan, M.D. & Associates
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Iowa Clinic
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital Clinical Research Center
    • Paducah, Kentucky, United States, 42003
      • Oncology Associates of West Kentucky
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Grand Blanc Surgical Specialist
  • New York
    • Albany, New York, United States, 12208
      • Albany Thoracic & Esophageal Surgery
    • East Setauket, New York, United States, 11733
      • North Shore Hematology Oncology
    • Flushing, New York, United States, 11355
      • The New York Hospital Medical Center of Queens
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Center for Clinical Research and Technology University Hospitals of Cleveland
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16505
      • The Regional Cancer Center
  • Texas
    • Houston, Texas, United States, 77090
      • Northwest Cancer Center
    • Houston, Texas, United States, 77054
      • Colorectal Surgical Associates
    • Houston, Texas, United States, 77024
      • Barry S Siller MD
    • San Antonio, Texas, United States, 78229
      • Cancer Care Centers of South Texas
  • Washington
    • Spokane, Washington, United States, 99202
      • Cancer Care Northwest
  • West Virginia
    • Morgantown, West Virginia, United States, 26508
      • Heiskell, King, Burns & Tallman Surgical Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with solid tumor malignancies

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.
To investigate the association between the results of Precision's ChemoFx assay results and overall survival in subjects with solid tumors.	From date of first dose of on-study chemotherapy to date of death or last known alive.

Collaborators and Investigators

• Sponsor: Precision Therapeutics
• Investigators: Principal Investigator: Karl Williams, M.D., Precision Therapeutics, Inc.

Publications and helpful links

Helpful Links

• Precision Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: January 5, 2011
• First Submitted That Met QC Criteria: January 6, 2011
• First Posted (Estimate): January 7, 2011

Study Record Updates

• Last Update Posted (Estimate): October 5, 2012
• Last Update Submitted That Met QC Criteria: October 4, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Adenocarcinoma; Refractory; Persistent; Cervical; Lung; Chemotherapy; Sarcoma; Breast; Mesothelioma; Recurrent; Vulva; Colorectal; Ovarian; Peritoneal; Endometrial; Carcinoid; Assay; Fallopian Tube; Uterine Neoplasms; Chemoresponse
• Other Study ID Numbers: PT-207