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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35213
- Cardio-Thoracic Surgeons, P.C.
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California
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Oakland, California, Stati Uniti, 94609
- Hematology Oncology Associates
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Florida
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Boynton Beach, Florida, Stati Uniti, 33435
- Collaborative Research Group
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Fort Lauderdale, Florida, Stati Uniti, 33308
- Broward Oncology Associates, P.A.
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Hollywood, Florida, Stati Uniti, 33021
- The Center For Gynecologic Oncology
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Miami, Florida, Stati Uniti, 33143
- GYN Oncology of Miami
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Miami, Florida, Stati Uniti, 33173
- Miami International Surgical Services
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Orlando, Florida, Stati Uniti, 32804
- Orlando Cardiovascular Institute PA
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Illinois
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Skokie, Illinois, Stati Uniti, 60076
- Edward H. Kaplan, M.D. & Associates
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Iowa
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Des Moines, Iowa, Stati Uniti, 50309
- Iowa Clinic
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40503
- Central Baptist Hospital Clinical Research Center
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Paducah, Kentucky, Stati Uniti, 42003
- Oncology Associates of West Kentucky
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Michigan
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Grand Blanc, Michigan, Stati Uniti, 48439
- Grand Blanc Surgical Specialist
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New York
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Albany, New York, Stati Uniti, 12208
- Albany Thoracic & Esophageal Surgery
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East Setauket, New York, Stati Uniti, 11733
- North Shore Hematology Oncology
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Flushing, New York, Stati Uniti, 11355
- The New York Hospital Medical Center of Queens
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Mineola, New York, Stati Uniti, 11501
- Winthrop University Hospital
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Ohio
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Cleveland, Ohio, Stati Uniti, 44106
- Center for Clinical Research and Technology University Hospitals of Cleveland
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Pennsylvania
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Erie, Pennsylvania, Stati Uniti, 16505
- The Regional Cancer Center
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Texas
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Houston, Texas, Stati Uniti, 77090
- Northwest Cancer Center
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Houston, Texas, Stati Uniti, 77054
- Colorectal Surgical Associates
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Houston, Texas, Stati Uniti, 77024
- Barry S Siller MD
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San Antonio, Texas, Stati Uniti, 78229
- Cancer Care Centers of South Texas
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Washington
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Spokane, Washington, Stati Uniti, 99202
- Cancer Care Northwest
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West Virginia
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Morgantown, West Virginia, Stati Uniti, 26508
- Heiskell, King, Burns & Tallman Surgical Associates, Inc.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
Lasso di tempo: Analysis of assay-directed compliance will be conducted immediately after information is collected.
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Analysis of assay-directed compliance will be conducted immediately after information is collected.
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To investigate the association between the results of Precision's ChemoFx assay results and overall survival in subjects with solid tumors.
Lasso di tempo: From date of first dose of on-study chemotherapy to date of death or last known alive.
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From date of first dose of on-study chemotherapy to date of death or last known alive.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Karl Williams, M.D., Precision Therapeutics, Inc.
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- PT-207
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