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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35213
- Cardio-Thoracic Surgeons, P.C.
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California
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Oakland, California, Forenede Stater, 94609
- Hematology Oncology Associates
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Florida
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Boynton Beach, Florida, Forenede Stater, 33435
- Collaborative Research Group
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Broward Oncology Associates, P.A.
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Hollywood, Florida, Forenede Stater, 33021
- The Center For Gynecologic Oncology
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Miami, Florida, Forenede Stater, 33143
- GYN Oncology of Miami
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Miami, Florida, Forenede Stater, 33173
- Miami International Surgical Services
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Orlando, Florida, Forenede Stater, 32804
- Orlando Cardiovascular Institute PA
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Illinois
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Skokie, Illinois, Forenede Stater, 60076
- Edward H. Kaplan, M.D. & Associates
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Iowa
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Des Moines, Iowa, Forenede Stater, 50309
- Iowa Clinic
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
- Central Baptist Hospital Clinical Research Center
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Paducah, Kentucky, Forenede Stater, 42003
- Oncology Associates of West Kentucky
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Michigan
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Grand Blanc, Michigan, Forenede Stater, 48439
- Grand Blanc Surgical Specialist
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New York
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Albany, New York, Forenede Stater, 12208
- Albany Thoracic & Esophageal Surgery
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East Setauket, New York, Forenede Stater, 11733
- North Shore Hematology Oncology
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Flushing, New York, Forenede Stater, 11355
- The New York Hospital Medical Center of Queens
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Mineola, New York, Forenede Stater, 11501
- Winthrop University Hospital
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Center for Clinical Research and Technology University Hospitals of Cleveland
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Pennsylvania
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Erie, Pennsylvania, Forenede Stater, 16505
- The Regional Cancer Center
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Texas
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Houston, Texas, Forenede Stater, 77090
- Northwest Cancer Center
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Houston, Texas, Forenede Stater, 77054
- Colorectal Surgical Associates
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Houston, Texas, Forenede Stater, 77024
- Barry S Siller MD
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San Antonio, Texas, Forenede Stater, 78229
- Cancer Care Centers of South Texas
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Washington
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Spokane, Washington, Forenede Stater, 99202
- Cancer Care Northwest
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West Virginia
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Morgantown, West Virginia, Forenede Stater, 26508
- Heiskell, King, Burns & Tallman Surgical Associates, Inc.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
Tidsramme: 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.
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Karl Williams, M.D., Precision Therapeutics, Inc.
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- PT-207
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