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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35213
- Cardio-Thoracic Surgeons, P.C.
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California
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Oakland, California, Estados Unidos, 94609
- Hematology Oncology Associates
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Florida
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Boynton Beach, Florida, Estados Unidos, 33435
- Collaborative Research Group
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Fort Lauderdale, Florida, Estados Unidos, 33308
- Broward Oncology Associates, P.A.
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Hollywood, Florida, Estados Unidos, 33021
- The Center For Gynecologic Oncology
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Miami, Florida, Estados Unidos, 33143
- GYN Oncology of Miami
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Miami, Florida, Estados Unidos, 33173
- Miami International Surgical Services
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Orlando, Florida, Estados Unidos, 32804
- Orlando Cardiovascular Institute PA
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Illinois
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Skokie, Illinois, Estados Unidos, 60076
- Edward H. Kaplan, M.D. & Associates
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Iowa
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Des Moines, Iowa, Estados Unidos, 50309
- Iowa Clinic
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
- Central Baptist Hospital Clinical Research Center
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Paducah, Kentucky, Estados Unidos, 42003
- Oncology Associates of West Kentucky
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Michigan
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Grand Blanc, Michigan, Estados Unidos, 48439
- Grand Blanc Surgical Specialist
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New York
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Albany, New York, Estados Unidos, 12208
- Albany Thoracic & Esophageal Surgery
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East Setauket, New York, Estados Unidos, 11733
- North Shore Hematology Oncology
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Flushing, New York, Estados Unidos, 11355
- The New York Hospital Medical Center of Queens
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Mineola, New York, Estados Unidos, 11501
- Winthrop University Hospital
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- Center for Clinical Research and Technology University Hospitals of Cleveland
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Pennsylvania
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Erie, Pennsylvania, Estados Unidos, 16505
- The Regional Cancer Center
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Texas
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Houston, Texas, Estados Unidos, 77090
- Northwest Cancer Center
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Houston, Texas, Estados Unidos, 77054
- Colorectal Surgical Associates
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Houston, Texas, Estados Unidos, 77024
- Barry S Siller MD
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San Antonio, Texas, Estados Unidos, 78229
- Cancer Care Centers of South Texas
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Washington
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Spokane, Washington, Estados Unidos, 99202
- Cancer Care Northwest
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West Virginia
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Morgantown, West Virginia, Estados Unidos, 26508
- Heiskell, King, Burns & Tallman Surgical Associates, Inc.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
Periodo de tiempo: 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.
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Karl Williams, M.D., Precision Therapeutics, Inc.
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- PT-207
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