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
1 other identifier
observational
167
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2010
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 5, 2011
CompletedFirst Posted
Study publicly available on registry
January 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 5, 2012
October 1, 2012
1.9 years
January 5, 2011
October 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Eligibility Criteria
Subjects with solid tumor malignancies
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, 35213, United States
Hematology Oncology Associates
Oakland, California, 94609, United States
Collaborative Research Group
Boynton Beach, Florida, 33435, United States
Broward Oncology Associates, P.A.
Fort Lauderdale, Florida, 33308, United States
The Center For Gynecologic Oncology
Hollywood, Florida, 33021, United States
GYN Oncology of Miami
Miami, Florida, 33143, United States
Miami International Surgical Services
Miami, Florida, 33173, United States
Orlando Cardiovascular Institute PA
Orlando, Florida, 32804, United States
Edward H. Kaplan, M.D. & Associates
Skokie, Illinois, 60076, United States
Iowa Clinic
Des Moines, Iowa, 50309, United States
Central Baptist Hospital Clinical Research Center
Lexington, Kentucky, 40503, United States
Oncology Associates of West Kentucky
Paducah, Kentucky, 42003, United States
Grand Blanc Surgical Specialist
Grand Blanc, Michigan, 48439, United States
Albany Thoracic & Esophageal Surgery
Albany, New York, 12208, United States
North Shore Hematology Oncology
East Setauket, New York, 11733, United States
The New York Hospital Medical Center of Queens
Flushing, New York, 11355, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Center for Clinical Research and Technology University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
The Regional Cancer Center
Erie, Pennsylvania, 16505, United States
Barry S Siller MD
Houston, Texas, 77024, United States
Colorectal Surgical Associates
Houston, Texas, 77054, United States
Northwest Cancer Center
Houston, Texas, 77090, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78229, United States
Cancer Care Northwest
Spokane, Washington, 99202, United States
Heiskell, King, Burns & Tallman Surgical Associates, Inc.
Morgantown, West Virginia, 26508, United States
Biospecimen
DNA, RNA, and proteomic research will be conducted on excess tissue cells.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karl Williams, M.D.
Precision Therapeutics, Inc.
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2011
First Posted
January 7, 2011
Study Start
November 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
October 5, 2012
Record last verified: 2012-10