- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00860041
Acute Pain Caused by Paclitaxel in Patients With Cancer
Paclitaxel-Associated Acute Pain Syndrome Natural History Study
RATIONALE: Gathering information over time from patients receiving paclitaxel for cancer may help doctors learn more about pain caused by paclitaxel and plan the best treatment.
PURPOSE: This clinical trial is studying acute pain caused by paclitaxel in patients with cancer.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
OBJECTIVES:
- To describe the incidence and characteristics of and change in pain related to paclitaxel infusions over several courses in patients receiving paclitaxel weekly or every 2-4 weeks with or without neurotoxic chemotherapy.
- To investigate the association between paclitaxel-induced acute pain syndrome symptoms and eventual chemotherapy-induced neuropathy.
- To perform exome-sequencing analysis and identify genetic variants that predict paclitaxel- induced peripheral neuropathy.
- To identify clinical phenotypes associated with paclitaxel toxicity (i.e., acute pain syndrome and neuropathy).
- To explore whether there are any evident differences between results seen in the majority Caucasian population and the minority populations.
OUTLINE: This is a multicenter study. Patients are grouped according to paclitaxel dosing schedule (weekly vs every 2-4 weeks) and concurrent use of neurotoxic agent (yes vs no).
Blood samples are collected at baseline for correlative laboratory studies, including genetic biomarker and polymorphism studies.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Stany Zjednoczone, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Stany Zjednoczone, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Stany Zjednoczone, 80210
- Porter Adventist Hospital
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Denver, Colorado, Stany Zjednoczone, 80220
- Rose Medical Center
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Denver, Colorado, Stany Zjednoczone, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Stany Zjednoczone, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Stany Zjednoczone, 80218
- St. Joseph Hospital
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Denver, Colorado, Stany Zjednoczone, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Stany Zjednoczone, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Stany Zjednoczone, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Stany Zjednoczone, 80631
- North Colorado Medical Center
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Littleton, Colorado, Stany Zjednoczone, 80122
- Littleton Adventist Hospital
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Lone Tree, Colorado, Stany Zjednoczone, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Stany Zjednoczone, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Stany Zjednoczone, 80539
- McKee Medical Center
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Parker, Colorado, Stany Zjednoczone, 80138
- Parker Adventist Hospital
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Pueblo, Colorado, Stany Zjednoczone, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Stany Zjednoczone, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Stany Zjednoczone, 80033
- Exempla Lutheran Medical Center
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Connecticut
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Hartford, Connecticut, Stany Zjednoczone, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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Hawaii
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Aiea, Hawaii, Stany Zjednoczone, 96701
- Kapiolani Medical Center at Pali Momi
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Stany Zjednoczone, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- OnCare Hawaii, Incorporated - Lusitana
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- Queen's Cancer Institute at Queen's Medical Center
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Honolulu, Hawaii, Stany Zjednoczone, 96813
- Straub Clinic and Hospital, Incorporated
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Honolulu, Hawaii, Stany Zjednoczone, 96817
- Hawaii Medical Center - East
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Honolulu, Hawaii, Stany Zjednoczone, 96817
- OnCare Hawaii, Incorporated - Kuakini
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Honolulu, Hawaii, Stany Zjednoczone, 96859
- Tripler Army Medical Center
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Lihue, Hawaii, Stany Zjednoczone, 96766
- Kauai Medical Clinic
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Wailuku, Hawaii, Stany Zjednoczone, 96793
- Maui Memorial Medical Center
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Wailuku, Hawaii, Stany Zjednoczone, 96793
- Pacific Cancer Institute - Maui
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Idaho
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Boise, Idaho, Stany Zjednoczone, 83706
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
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Illinois
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Bloomington, Illinois, Stany Zjednoczone, 61701
- St. Joseph Medical Center
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Bloomington%, Illinois, Stany Zjednoczone, 61701
- Illinois CancerCare - Bloomington
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Canton, Illinois, Stany Zjednoczone, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Stany Zjednoczone, 61520
- Graham Hospital
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Carthage, Illinois, Stany Zjednoczone, 62321
- Memorial Hospital
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Carthage, Illinois, Stany Zjednoczone, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Stany Zjednoczone, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Stany Zjednoczone, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Stany Zjednoczone, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, Stany Zjednoczone, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Stany Zjednoczone, 62644
- Mason District Hospital
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Havana, Illinois, Stany Zjednoczone, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Stany Zjednoczone, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Stany Zjednoczone, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Stany Zjednoczone, 61455
- Mcdonough District Hospital
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Moline, Illinois, Stany Zjednoczone, 61265
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Moline, Illinois, Stany Zjednoczone, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Stany Zjednoczone, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, Stany Zjednoczone, 61462
- OSF Holy Family Medical Center
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Normal, Illinois, Stany Zjednoczone, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Stany Zjednoczone, 61761
- Community Cancer Center
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Normal, Illinois, Stany Zjednoczone, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Stany Zjednoczone, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Stany Zjednoczone, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Stany Zjednoczone, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Stany Zjednoczone, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Stany Zjednoczone, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Stany Zjednoczone, 61614
- Proctor Hospital
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Peoria, Illinois, Stany Zjednoczone, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Stany Zjednoczone, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Stany Zjednoczone, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Stany Zjednoczone, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Stany Zjednoczone, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Stany Zjednoczone, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Stany Zjednoczone, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Stany Zjednoczone, 61362
- Illinois CancerCare - Spring Valley
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Indiana
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Elkhart, Indiana, Stany Zjednoczone, 46515
- Elkhart General Hospital
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Elkhart, Indiana, Stany Zjednoczone, 46514
- Michiana Hematology-Oncology, PC - Elkhart
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Kokomo, Indiana, Stany Zjednoczone, 46904
- Howard Community Hospital
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La Porte, Indiana, Stany Zjednoczone, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, Stany Zjednoczone, 46545-1470
- Michiana Hematology-Oncology, PC - South Bend
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Mishawaka, Indiana, Stany Zjednoczone, 46545-1470
- Saint Joseph Regional Medical Center
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Plymouth, Indiana, Stany Zjednoczone, 46563
- Michiana Hematology Oncology PC - Plymouth
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South Bend, Indiana, Stany Zjednoczone, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Stany Zjednoczone, 46601
- CCOP - Northern Indiana CR Consortium
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Westville, Indiana, Stany Zjednoczone, 46391
- Michiana Hematology Oncology PC - La Porte
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Iowa
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Ames, Iowa, Stany Zjednoczone, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, Stany Zjednoczone, 52722
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Cedar Rapids, Iowa, Stany Zjednoczone, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Stany Zjednoczone, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Clive, Iowa, Stany Zjednoczone, 50325
- Medical Oncology and Hematology Associates - West Des Moines
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Des Moines, Iowa, Stany Zjednoczone, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Stany Zjednoczone, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Stany Zjednoczone, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Stany Zjednoczone, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Stany Zjednoczone, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stany Zjednoczone, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Mason City, Iowa, Stany Zjednoczone, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, Stany Zjednoczone, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, Stany Zjednoczone, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Stany Zjednoczone, 51102
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, Stany Zjednoczone, 51104
- St. Luke's Regional Medical Center
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Kansas
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Chanute, Kansas, Stany Zjednoczone, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Stany Zjednoczone, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Stany Zjednoczone, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Stany Zjednoczone, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Stany Zjednoczone, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Stany Zjednoczone, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Stany Zjednoczone, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Stany Zjednoczone, 67901
- Cancer Center of Kansas, PA - Liberal
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McPherson, Kansas, Stany Zjednoczone, 67460
- Cancer Center of Kansas, PA - McPherson
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Newton, Kansas, Stany Zjednoczone, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Stany Zjednoczone, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Stany Zjednoczone, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Stany Zjednoczone, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Stany Zjednoczone, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Stany Zjednoczone, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Stany Zjednoczone, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Stany Zjednoczone, 67214
- CCOP - Wichita
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Wichita, Kansas, Stany Zjednoczone, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Stany Zjednoczone, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Stany Zjednoczone, 67156
- Cancer Center of Kansas, PA - Winfield
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Louisiana
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Baton Rouge, Louisiana, Stany Zjednoczone, 70809
- Ochsner Health Center - Bluebonnet
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New Orleans, Louisiana, Stany Zjednoczone, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Stany Zjednoczone, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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Michigan
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Adrian, Michigan, Stany Zjednoczone, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Stany Zjednoczone, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Stany Zjednoczone, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Stany Zjednoczone, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Stany Zjednoczone, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, Stany Zjednoczone, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Stany Zjednoczone, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Stany Zjednoczone, 48503
- Hurley Medical Center
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Flint, Michigan, Stany Zjednoczone, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Stany Zjednoczone, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Stany Zjednoczone, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Stany Zjednoczone, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, Stany Zjednoczone, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Stany Zjednoczone, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Stany Zjednoczone, 49201
- Foote Memorial Hospital
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Lansing, Michigan, Stany Zjednoczone, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Stany Zjednoczone, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, Stany Zjednoczone, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Stany Zjednoczone, 48162
- Mercy Memorial Hospital - Monroe
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Muskegon, Michigan, Stany Zjednoczone, 49443
- Mercy General Health Partners
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Pontiac, Michigan, Stany Zjednoczone, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Stany Zjednoczone, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Stany Zjednoczone, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Saint Joseph, Michigan, Stany Zjednoczone, 49085
- Lakeside Cancer Specialists, PLLC
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St. Joseph, Michigan, Stany Zjednoczone, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Traverse City, Michigan, Stany Zjednoczone, 49684
- Munson Medical Center
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Warren, Michigan, Stany Zjednoczone, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, Stany Zjednoczone, 56308
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Bemidji, Minnesota, Stany Zjednoczone, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Stany Zjednoczone, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Stany Zjednoczone, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Stany Zjednoczone, 55805
- CCOP - Duluth
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Duluth, Minnesota, Stany Zjednoczone, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Stany Zjednoczone, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Stany Zjednoczone, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Stany Zjednoczone, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Stany Zjednoczone, 55350
- Hutchinson Area Health Care
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Mankato, Minnesota, Stany Zjednoczone, 56002
- Immanuel St. Joseph's
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Maplewood, Minnesota, Stany Zjednoczone, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, Stany Zjednoczone, 55109
- Minnesota Oncology - Maplewood
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Minneapolis, Minnesota, Stany Zjednoczone, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Stany Zjednoczone, 55415
- Hennepin County Medical Center - Minneapolis
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New Ulm, Minnesota, Stany Zjednoczone, 56073
- New Ulm Medical Center
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Robbinsdale, Minnesota, Stany Zjednoczone, 55422-2900
- Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Stany Zjednoczone, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Stany Zjednoczone, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Stany Zjednoczone, 55102
- United Hospital
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Shakopee, Minnesota, Stany Zjednoczone, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St. Paul, Minnesota, Stany Zjednoczone, 55101
- Regions Hospital Cancer Care Center
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Stillwater, Minnesota, Stany Zjednoczone, 55082
- Lakeview Hospital
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Waconia, Minnesota, Stany Zjednoczone, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Stany Zjednoczone, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, Stany Zjednoczone, 55125
- Minnesota Oncology - Woodbury
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Missouri
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Cape Girardeau, Missouri, Stany Zjednoczone, 63703
- Southeast Cancer Center
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Jefferson City, Missouri, Stany Zjednoczone, 65109
- Goldschmidt Cancer Center
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Saint Louis, Missouri, Stany Zjednoczone, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, Stany Zjednoczone, 63141
- Comprehensive Cancer Care, PC
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Montana
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Billings, Montana, Stany Zjednoczone, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Stany Zjednoczone, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Stany Zjednoczone, 59107-7000
- Billings Clinic - Downtown
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Billings, Montana, Stany Zjednoczone, 59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Bozeman, Montana, Stany Zjednoczone, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Stany Zjednoczone, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Stany Zjednoczone, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Stany Zjednoczone, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Havre, Montana, Stany Zjednoczone, 59501
- Northern Montana Hospital
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Helena, Montana, Stany Zjednoczone, 59601
- St. Peter's Hospital
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Kalispell, Montana, Stany Zjednoczone, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Stany Zjednoczone, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Stany Zjednoczone, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Stany Zjednoczone, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Stany Zjednoczone, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Lincoln, Nebraska, Stany Zjednoczone, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Stany Zjednoczone, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Stany Zjednoczone, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Stany Zjednoczone, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Stany Zjednoczone, 68131-2197
- Creighton University Medical Center
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Omaha, Nebraska, Stany Zjednoczone, 68130
- Lakeside Hospital
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North Dakota
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Bismarck, North Dakota, Stany Zjednoczone, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Stany Zjednoczone, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Stany Zjednoczone, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Stany Zjednoczone, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Stany Zjednoczone, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Stany Zjednoczone, 58102
- MeritCare Broadway
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Fargo, North Dakota, Stany Zjednoczone, 58122
- Roger Maris Cancer Center at MeritCare Hospital
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Ohio
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Bowling Green, Ohio, Stany Zjednoczone, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, Stany Zjednoczone, 45601
- Adena Regional Medical Center
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Columbus, Ohio, Stany Zjednoczone, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Stany Zjednoczone, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, Stany Zjednoczone, 43215
- CCOP - Columbus
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Columbus, Ohio, Stany Zjednoczone, 43215
- Grant Medical Center Cancer Care
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Columbus, Ohio, Stany Zjednoczone, 43228
- Doctors Hospital at Ohio Health
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Delaware, Ohio, Stany Zjednoczone, 43015
- Grady Memorial Hospital
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Elyria, Ohio, Stany Zjednoczone, 44035
- Community Cancer Center
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Elyria, Ohio, Stany Zjednoczone, 44035
- Hematology Oncology Center
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Lancaster, Ohio, Stany Zjednoczone, 43130
- Fairfield Medical Center
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Lima, Ohio, Stany Zjednoczone, 45804
- Lima Memorial Hospital
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Marietta, Ohio, Stany Zjednoczone, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Maumee, Ohio, Stany Zjednoczone, 43537-1839
- Northwest Ohio Oncology Center
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Mount Vernon, Ohio, Stany Zjednoczone, 43050
- Knox Community Hospital
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Newark, Ohio, Stany Zjednoczone, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Norwalk, Ohio, Stany Zjednoczone, 44857
- Fisher-Titus Medical Center
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Oregon, Ohio, Stany Zjednoczone, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Stany Zjednoczone, 43616
- Toledo Clinic - Oregon
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Portsmouth, Ohio, Stany Zjednoczone, 45662
- Southern Ohio Medical Center Cancer Center
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Sandusky, Ohio, Stany Zjednoczone, 44870
- North Coast Cancer Care, Incorporated
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Springfield, Ohio, Stany Zjednoczone, 45505
- Community Hospital of Springfield and Clark County
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Sylvania, Ohio, Stany Zjednoczone, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Stany Zjednoczone, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Stany Zjednoczone, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Stany Zjednoczone, 43606
- Toledo Hospital
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Toledo, Ohio, Stany Zjednoczone, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, Stany Zjednoczone, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, Stany Zjednoczone, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, Stany Zjednoczone, 43623
- St. Anne Mercy Hospital
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Wauseon, Ohio, Stany Zjednoczone, 43567
- Fulton County Health Center
-
Westerville, Ohio, Stany Zjednoczone, 43081
- Mount Carmel St. Ann's Cancer Center
-
Zanesville, Ohio, Stany Zjednoczone, 43701
- Genesis - Good Samaritan Hospital
-
-
Oklahoma
-
Tulsa, Oklahoma, Stany Zjednoczone, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Oregon
-
Clackamas, Oregon, Stany Zjednoczone, 97015
- Clackamas Radiation Oncology Center
-
Milwaukie, Oregon, Stany Zjednoczone, 97222
- Providence Milwaukie Hospital
-
Newberg, Oregon, Stany Zjednoczone, 97132
- Providence Newberg Medical Center
-
Oregon City, Oregon, Stany Zjednoczone, 97045
- Willamette Falls Hospital
-
Portland, Oregon, Stany Zjednoczone, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
-
Portland, Oregon, Stany Zjednoczone, 97225
- CCOP - Columbia River Oncology Program
-
Portland, Oregon, Stany Zjednoczone, 97225
- Providence St. Vincent Medical Center
-
-
Pennsylvania
-
Danville, Pennsylvania, Stany Zjednoczone, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Hazleton, Pennsylvania, Stany Zjednoczone, 18201
- Geisinger Hazleton Cancer Center
-
State College, Pennsylvania, Stany Zjednoczone, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, Stany Zjednoczone, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Stany Zjednoczone, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Stany Zjednoczone, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, Stany Zjednoczone, 22401
- Fredericksburg Oncology, Incorporated
-
Richmond, Virginia, Stany Zjednoczone, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
-
-
Washington
-
Seattle, Washington, Stany Zjednoczone, 98101
- Virginia Mason Medical Center
-
Seattle, Washington, Stany Zjednoczone, 98101
- CCOP - Virginia Mason Research Center
-
Vancouver, Washington, Stany Zjednoczone, 98664
- Southwest Washington Medical Center Cancer Center
-
-
Wisconsin
-
Chippewa Falls, Wisconsin, Stany Zjednoczone, 54729
- Marshfield Clinic - Chippewa Center
-
Eau Claire, Wisconsin, Stany Zjednoczone, 54701
- Marshfield Clinic Cancer Care at Regional Cancer Center
-
Fond du Lac, Wisconsin, Stany Zjednoczone, 54935
- Central Wisconsin Cancer Program at Agnesian HealthCare
-
Green Bay, Wisconsin, Stany Zjednoczone, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Stany Zjednoczone, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Stany Zjednoczone, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Stany Zjednoczone, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Manitowoc, Wisconsin, Stany Zjednoczone, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
-
Marinette, Wisconsin, Stany Zjednoczone, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Marshfield, Wisconsin, Stany Zjednoczone, 54449
- Marshfield Clinic - Marshfield Center
-
Minocqua, Wisconsin, Stany Zjednoczone, 54548
- Marshfield Clinic - Lakeland Center
-
Oconto Falls, Wisconsin, Stany Zjednoczone, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Rhinelander, Wisconsin, Stany Zjednoczone, 54501
- Ministry Medical Group at Saint Mary's Hospital
-
Rice Lake, Wisconsin, Stany Zjednoczone, 54868
- Marshfield Clinic - Indianhead Center
-
Sheboygan, Wisconsin, Stany Zjednoczone, 53081
- St. Nicholas Hospital
-
Stevens Point, Wisconsin, Stany Zjednoczone, 54481
- Marshfield Clinic at Saint Michael's Hospital
-
Sturgeon Bay, Wisconsin, Stany Zjednoczone, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
Weston, Wisconsin, Stany Zjednoczone, 54476
- Marshfield Clinic - Weston Center
-
Wisconsin Rapids, Wisconsin, Stany Zjednoczone, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Wyoming
-
Sheridan, Wyoming, Stany Zjednoczone, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
Planning to receive paclitaxel IV (excluding paclitaxel albumin-stabilized nanoparticle formulation [nab-paclitaxel]) according to one of the following dosing schedules:
- At least 175 mg/m^2 at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively)
- 70-90 mg/m^2 weekly (3 out of 4 weeks allowed)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 6 months
- Able to complete questionnaires (alone or with assistance)
- Willing to provide required biological specimens
- No prior or concurrent peripheral neuropathy (from diabetes or other causes)
- No prior or concurrent fibromyalgia
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior paclitaxel or neurotoxic chemotherapy drugs, including other taxanes, platinum agents, vinca alkaloids, or epothilones
- No concurrent neutrophil colony-stimulating factor therapy
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Group I
Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year.
Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.
|
|
|
Group II
Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year.
Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.
|
|
|
Group III
Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year.
Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.
|
|
|
Group IV
Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year.
Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy)
Ramy czasowe: Up to day 7
|
Up to day 7
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Maximum of the average pain score
Ramy czasowe: Up to 12 months
|
Up to 12 months
|
|
Area under the curve of worst, average, and least pain
Ramy czasowe: Up to 12 months
|
Up to 12 months
|
|
Worst pain reported for the overall week
Ramy czasowe: Up to 12 months
|
Up to 12 months
|
|
Rate of non-prescription pain medication use
Ramy czasowe: Up to 12 months
|
Up to 12 months
|
|
Rate of opioid use
Ramy czasowe: Up to 12 months
|
Up to 12 months
|
|
Rate of other pain therapy use
Ramy czasowe: Up to 12 months
|
Up to 12 months
|
|
Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores
Ramy czasowe: Up to 12 months
|
Up to 12 months
|
Współpracownicy i badacze
Współpracownicy
Publikacje i pomocne linki
Publikacje ogólne
- Reeves BN, Dakhil SR, Sloan JA, Wolf SL, Burger KN, Kamal A, Le-Lindqwister NA, Soori GS, Jaslowski AJ, Kelaghan J, Novotny PJ, Lachance DH, Loprinzi CL. Further data supporting that paclitaxel-associated acute pain syndrome is associated with development of peripheral neuropathy: North Central Cancer Treatment Group trial N08C1. Cancer. 2012 Oct 15;118(20):5171-8. doi: 10.1002/cncr.27489. Epub 2012 Mar 13.
- Loprinzi CL, Reeves BN, Dakhil SR, Sloan JA, Wolf SL, Burger KN, Kamal A, Le-Lindqwister NA, Soori GS, Jaslowski AJ, Novotny PJ, Lachance DH. Natural history of paclitaxel-associated acute pain syndrome: prospective cohort study NCCTG N08C1. J Clin Oncol. 2011 Apr 10;29(11):1472-8. doi: 10.1200/JCO.2010.33.0308. Epub 2011 Mar 7.
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
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NCCTG-N08C1
- NCI-2009-01108 (Identyfikator rejestru: CTRP (Clinical Trials Reporting System))
- CDR0000631962 (Identyfikator rejestru: PDQ (Physician Data Query))
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