A Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study
- Conditions
- Solid Organ Tumors
- Registration Number
- NCT01271959
- Lead Sponsor
- Precision Therapeutics
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 167
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
The Center For Gynecologic Oncology
🇺🇸Hollywood, Florida, United States
Oncology Associates of West Kentucky
🇺🇸Paducah, Kentucky, United States
Albany Thoracic & Esophageal Surgery
🇺🇸Albany, New York, United States
The Regional Cancer Center
🇺🇸Erie, Pennsylvania, United States
Heiskell, King, Burns & Tallman Surgical Associates, Inc.
🇺🇸Morgantown, West Virginia, United States
Barry S Siller MD
🇺🇸Houston, Texas, United States
Northwest Cancer Center
🇺🇸Houston, Texas, United States
Colorectal Surgical Associates
🇺🇸Houston, Texas, United States
Broward Oncology Associates, P.A.
🇺🇸Fort Lauderdale, Florida, United States
Center for Clinical Research and Technology University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
The New York Hospital Medical Center of Queens
🇺🇸Flushing, New York, United States
Collaborative Research Group
🇺🇸Boynton Beach, Florida, United States
Grand Blanc Surgical Specialist
🇺🇸Grand Blanc, Michigan, United States
Edward H. Kaplan, M.D. & Associates
🇺🇸Skokie, Illinois, United States
Iowa Clinic
🇺🇸Des Moines, Iowa, United States
North Shore Hematology Oncology
🇺🇸East Setauket, New York, United States
Central Baptist Hospital Clinical Research Center
🇺🇸Lexington, Kentucky, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Hematology Oncology Associates
🇺🇸Oakland, California, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
GYN Oncology of Miami
🇺🇸Miami, Florida, United States
Cardio-Thoracic Surgeons, P.C.
🇺🇸Birmingham, Alabama, United States
Miami International Surgical Services
🇺🇸Miami, Florida, United States
Orlando Cardiovascular Institute PA
🇺🇸Orlando, Florida, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States