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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
Alabama
-
Birmingham, Alabama, Vereinigte Staaten, 35213
- Cardio-Thoracic Surgeons, P.C.
-
-
California
-
Oakland, California, Vereinigte Staaten, 94609
- Hematology Oncology Associates
-
-
Florida
-
Boynton Beach, Florida, Vereinigte Staaten, 33435
- Collaborative Research Group
-
Fort Lauderdale, Florida, Vereinigte Staaten, 33308
- Broward Oncology Associates, P.A.
-
Hollywood, Florida, Vereinigte Staaten, 33021
- The Center For Gynecologic Oncology
-
Miami, Florida, Vereinigte Staaten, 33143
- GYN Oncology of Miami
-
Miami, Florida, Vereinigte Staaten, 33173
- Miami International Surgical Services
-
Orlando, Florida, Vereinigte Staaten, 32804
- Orlando Cardiovascular Institute PA
-
-
Illinois
-
Skokie, Illinois, Vereinigte Staaten, 60076
- Edward H. Kaplan, M.D. & Associates
-
-
Iowa
-
Des Moines, Iowa, Vereinigte Staaten, 50309
- Iowa Clinic
-
-
Kentucky
-
Lexington, Kentucky, Vereinigte Staaten, 40503
- Central Baptist Hospital Clinical Research Center
-
Paducah, Kentucky, Vereinigte Staaten, 42003
- Oncology Associates of West Kentucky
-
-
Michigan
-
Grand Blanc, Michigan, Vereinigte Staaten, 48439
- Grand Blanc Surgical Specialist
-
-
New York
-
Albany, New York, Vereinigte Staaten, 12208
- Albany Thoracic & Esophageal Surgery
-
East Setauket, New York, Vereinigte Staaten, 11733
- North Shore Hematology Oncology
-
Flushing, New York, Vereinigte Staaten, 11355
- The New York Hospital Medical Center of Queens
-
Mineola, New York, Vereinigte Staaten, 11501
- Winthrop University Hospital
-
-
Ohio
-
Cleveland, Ohio, Vereinigte Staaten, 44106
- Center for Clinical Research and Technology University Hospitals of Cleveland
-
-
Pennsylvania
-
Erie, Pennsylvania, Vereinigte Staaten, 16505
- The Regional Cancer Center
-
-
Texas
-
Houston, Texas, Vereinigte Staaten, 77090
- Northwest Cancer Center
-
Houston, Texas, Vereinigte Staaten, 77054
- Colorectal Surgical Associates
-
Houston, Texas, Vereinigte Staaten, 77024
- Barry S Siller MD
-
San Antonio, Texas, Vereinigte Staaten, 78229
- Cancer Care Centers of South Texas
-
-
Washington
-
Spokane, Washington, Vereinigte Staaten, 99202
- Cancer Care Northwest
-
-
West Virginia
-
Morgantown, West Virginia, Vereinigte Staaten, 26508
- Heiskell, King, Burns & Tallman Surgical Associates, Inc.
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
Zeitfenster: Analysis of assay-directed compliance will be conducted immediately after information is collected.
|
Analysis of assay-directed compliance will be conducted immediately after information is collected.
|
|
To investigate the association between the results of Precision's ChemoFx assay results and overall survival in subjects with solid tumors.
Zeitfenster: From date of first dose of on-study chemotherapy to date of death or last known alive.
|
From date of first dose of on-study chemotherapy to date of death or last known alive.
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Karl Williams, M.D., Precision Therapeutics, Inc.
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- PT-207
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .