Weekly Broadcast Email 01/08/09

 The following updates were made the website for the week of January 5, 2009.

98308: (A Phase III Randomized, Double-Blind, Placebo Controlled Trial of North American Ginseng Extract (CVT-E002; COLD-fX®) to Prevent Respiratory Infection and Reduce Antibiotic Use in Patients with Chronic Lymphocytic Leukemia)

The original accrual goal for the Cold-FX study has been achieved with the final accrual number for all sites being 293. This study has broken all past WFU CCOP Research Base accrual records and everyone is to be commended for their efforts. This study is permanently closed as of 01/01/2009 and has been moved to the closed column of the protocol webpage. Amendment 5 has been added to the archived amendment page. This amendment does not include consent changes. The following table lists individual sites’ accrual information. This table can also be found on the website.

MD Group 98308
Accruals
Wake Forest University
Winston Salem, NC 6
Clinical Trials Support Unit 67
Alamance Regional
Burlington, NC 5
Hematology Oncology Associates of Central New York
East Syracuse, NY 8
Cedar Rapids Oncology Project
Cedar Rapids, IA 1
Christian Care Health Services
Newark, DE 15
Greenville CCOP
Greenville, SC 27
Heartland Research Consortium
St. Louis, MO 10
Central Illinois CCOP
Decatur, IL 7
Louisiana State University
New Orleans, LA 5
Michigan Cancer Research Consortium
Ann Arbor, MI 20
Metro Minnesota CCOP
St. Louis Park, MN 17
Ozarks Regional CCOP
Springfield, MO 13
North Shore University Hospital
Manhasset, NY 15
Sioux Community Cancer Consortium
Sioux Falls, SD 5
St. Louis – Cape Girardeau CCOP
St. Louis, MO 8
St. Vincent CCOP
Green Bay, WI 13
Siouxland Hematology Oncology Associates
Sioux City, IA 10
Upstate CCOP
Spartanburg, SC 13
SCCC
Winston Salem, NC 28
total 293

91105: (Phase III Double Blind, Placebo Controlled Study of Donepezil in Irradiated Brain Tumor Patients)
The 2008 Continuing Review documents have been added to the 91105 webpage.

Adverse Events:
The following adverse event was reported during the month of December. A PDF of the AE document has been attached to this email and a summary of the event can be found on the adverse event page of the website. Adverse Events for closed studies have been moved to an archived adverse event page which can be accessed from the main AE page.
97202:AE#50

Accrual Update:
In the month of December, 163 patients were accrued to CCCWFU CCOP Research Base trials. CTSU was the top accruing site with 44 patients, followed by the Greenville CCOP with 22 patients. See the Research Base website home page for accrual information on each site.

Quick Reference

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Phone 336-716-0891

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Protocol Information Office
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Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.