A Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study
NCT ID: NCT01271959
Last Updated: 2012-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
167 participants
OBSERVATIONAL
2010-11-30
2012-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RETROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Precision Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karl Williams, M.D.
Role: PRINCIPAL_INVESTIGATOR
Precision Therapeutics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, United States
Hematology Oncology Associates
Oakland, California, United States
Collaborative Research Group
Boynton Beach, Florida, United States
Broward Oncology Associates, P.A.
Fort Lauderdale, Florida, United States
The Center For Gynecologic Oncology
Hollywood, Florida, United States
GYN Oncology of Miami
Miami, Florida, United States
Miami International Surgical Services
Miami, Florida, United States
Orlando Cardiovascular Institute PA
Orlando, Florida, United States
Edward H. Kaplan, M.D. & Associates
Skokie, Illinois, United States
Iowa Clinic
Des Moines, Iowa, United States
Central Baptist Hospital Clinical Research Center
Lexington, Kentucky, United States
Oncology Associates of West Kentucky
Paducah, Kentucky, United States
Grand Blanc Surgical Specialist
Grand Blanc, Michigan, United States
Albany Thoracic & Esophageal Surgery
Albany, New York, United States
North Shore Hematology Oncology
East Setauket, New York, United States
The New York Hospital Medical Center of Queens
Flushing, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Center for Clinical Research and Technology University Hospitals of Cleveland
Cleveland, Ohio, United States
The Regional Cancer Center
Erie, Pennsylvania, United States
Barry S Siller MD
Houston, Texas, United States
Colorectal Surgical Associates
Houston, Texas, United States
Northwest Cancer Center
Houston, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Cancer Care Northwest
Spokane, Washington, United States
Heiskell, King, Burns & Tallman Surgical Associates, Inc.
Morgantown, West Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PT-207
Identifier Type: -
Identifier Source: org_study_id