- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01271959
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
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35213
- Cardio-Thoracic Surgeons, P.C.
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California
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Oakland, California, Stany Zjednoczone, 94609
- Hematology Oncology Associates
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Florida
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Boynton Beach, Florida, Stany Zjednoczone, 33435
- Collaborative Research Group
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Fort Lauderdale, Florida, Stany Zjednoczone, 33308
- Broward Oncology Associates, P.A.
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Hollywood, Florida, Stany Zjednoczone, 33021
- The Center For Gynecologic Oncology
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Miami, Florida, Stany Zjednoczone, 33143
- GYN Oncology of Miami
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Miami, Florida, Stany Zjednoczone, 33173
- Miami International Surgical Services
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Orlando, Florida, Stany Zjednoczone, 32804
- Orlando Cardiovascular Institute PA
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Illinois
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Skokie, Illinois, Stany Zjednoczone, 60076
- Edward H. Kaplan, M.D. & Associates
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Iowa
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Des Moines, Iowa, Stany Zjednoczone, 50309
- Iowa Clinic
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Kentucky
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Lexington, Kentucky, Stany Zjednoczone, 40503
- Central Baptist Hospital Clinical Research Center
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Paducah, Kentucky, Stany Zjednoczone, 42003
- Oncology Associates of West Kentucky
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Michigan
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Grand Blanc, Michigan, Stany Zjednoczone, 48439
- Grand Blanc Surgical Specialist
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New York
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Albany, New York, Stany Zjednoczone, 12208
- Albany Thoracic & Esophageal Surgery
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East Setauket, New York, Stany Zjednoczone, 11733
- North Shore Hematology Oncology
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Flushing, New York, Stany Zjednoczone, 11355
- The New York Hospital Medical Center of Queens
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Mineola, New York, Stany Zjednoczone, 11501
- Winthrop University Hospital
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44106
- Center for Clinical Research and Technology University Hospitals of Cleveland
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Pennsylvania
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Erie, Pennsylvania, Stany Zjednoczone, 16505
- The Regional Cancer Center
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Texas
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Houston, Texas, Stany Zjednoczone, 77090
- Northwest Cancer Center
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Houston, Texas, Stany Zjednoczone, 77054
- Colorectal Surgical Associates
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Houston, Texas, Stany Zjednoczone, 77024
- Barry S Siller MD
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San Antonio, Texas, Stany Zjednoczone, 78229
- Cancer Care Centers of South Texas
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Washington
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Spokane, Washington, Stany Zjednoczone, 99202
- Cancer Care Northwest
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West Virginia
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Morgantown, West Virginia, Stany Zjednoczone, 26508
- Heiskell, King, Burns & Tallman Surgical Associates, Inc.
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
Ramy czasowe: 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.
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Karl Williams, M.D., Precision Therapeutics, Inc.
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- PT-207
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Nowotwory narządów litych
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Hospices Civils de LyonZakończonyOrgan transplantacyjnyFrancja
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AstraZenecaRekrutacyjnyAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, rak żołądka, piersi i jajnikaHiszpania, Stany Zjednoczone, Belgia, Zjednoczone Królestwo, Francja, Węgry, Kanada, Republika Korei, Australia