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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Alabama
-
Birmingham, Alabama, États-Unis, 35213
- Cardio-Thoracic Surgeons, P.C.
-
-
California
-
Oakland, California, États-Unis, 94609
- Hematology Oncology Associates
-
-
Florida
-
Boynton Beach, Florida, États-Unis, 33435
- Collaborative Research Group
-
Fort Lauderdale, Florida, États-Unis, 33308
- Broward Oncology Associates, P.A.
-
Hollywood, Florida, États-Unis, 33021
- The Center For Gynecologic Oncology
-
Miami, Florida, États-Unis, 33143
- GYN Oncology of Miami
-
Miami, Florida, États-Unis, 33173
- Miami International Surgical Services
-
Orlando, Florida, États-Unis, 32804
- Orlando Cardiovascular Institute PA
-
-
Illinois
-
Skokie, Illinois, États-Unis, 60076
- Edward H. Kaplan, M.D. & Associates
-
-
Iowa
-
Des Moines, Iowa, États-Unis, 50309
- Iowa Clinic
-
-
Kentucky
-
Lexington, Kentucky, États-Unis, 40503
- Central Baptist Hospital Clinical Research Center
-
Paducah, Kentucky, États-Unis, 42003
- Oncology Associates of West Kentucky
-
-
Michigan
-
Grand Blanc, Michigan, États-Unis, 48439
- Grand Blanc Surgical Specialist
-
-
New York
-
Albany, New York, États-Unis, 12208
- Albany Thoracic & Esophageal Surgery
-
East Setauket, New York, États-Unis, 11733
- North Shore Hematology Oncology
-
Flushing, New York, États-Unis, 11355
- The New York Hospital Medical Center of Queens
-
Mineola, New York, États-Unis, 11501
- Winthrop University Hospital
-
-
Ohio
-
Cleveland, Ohio, États-Unis, 44106
- Center for Clinical Research and Technology University Hospitals of Cleveland
-
-
Pennsylvania
-
Erie, Pennsylvania, États-Unis, 16505
- The Regional Cancer Center
-
-
Texas
-
Houston, Texas, États-Unis, 77090
- Northwest Cancer Center
-
Houston, Texas, États-Unis, 77054
- Colorectal Surgical Associates
-
Houston, Texas, États-Unis, 77024
- Barry S Siller MD
-
San Antonio, Texas, États-Unis, 78229
- Cancer Care Centers of South Texas
-
-
Washington
-
Spokane, Washington, États-Unis, 99202
- Cancer Care Northwest
-
-
West Virginia
-
Morgantown, West Virginia, États-Unis, 26508
- Heiskell, King, Burns & Tallman Surgical Associates, Inc.
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
Délai: 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.
Délai: 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.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Karl Williams, M.D., Precision Therapeutics, Inc.
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- PT-207
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .