MammoSite Patient Registry

The American Society of Breast Surgeons has established the largest compilation of data on the use of partial breast irradiation to treat breast cancer, through the MammoSite Patient Registry. The Registry is a national data collection program designed to gather and analyze patient information on the use, complications, and outcomes in patients treated with MammoSite. Enrollment closed in 2004 however the study is ongoing until patients have completed their 7 year follow up. Follow up remains important for without long term follow up the data will lose its value.

ANNOUNCEMENT

Effective IMMEDIATELY, all Case Report Forms and data clarifications will be faxed to a new Contract Research Organization (CRO). BioStat International, Inc. (BSI) has been selected to provide all future data management services for The American Society of Breast Surgeons MammoSite Registry. BSI was evaluated by The Society and determined to have the experience and commitment necessary to provide the quality biostatistical and data management services required to meet the future needs of the Registry. BSI has over 25 years of experience providing the pharmaceutical and medical device community with biostatistics, data management and clinical management services in all phases of clinical trials. BSI is located at:

14506A University Point Place
Tampa, FL 33613
Telephone: (813) 979-1619
Fax: (813) 979-1519

Attached is a new Case Report Form Fax Transmission form that you should begin using IMMEDIATELY. The form reflects the new fax number of (813) 979-1519 to which forms should be faxed. Your contact at BSI should you have any questions regarding receipt of faxed forms is Sonia Rodriquez, Manager Clinical Data Systems, (813) 979-1619, X16.

We are excited to have BSI providing the data management services for the Registry and look forward to the future as we continue the ever important task of collecting the follow up data that is so important to the overall success of the Registry.

The most current fax transmission form, case report forms and guidelines for completion are below. Please use case report 3 (Rev H, March 2005) and case report 4, pages 1 and 2 (Rev G, July 2004) for all follow-up visits and to report any adverse events.

If you have any questions, please contact Stephani Oliveri, by email stephani.oliveri@cytyc.com or by phone (770-893-9165).

Resources

• RecurrenceCase Report Form *NEW*
• Case Report Form Fax Transmission Form
• Guidelines for Completing Case Report Forms 3 and 4
• MammoSite RTS Registry - Case Report Form 3 - Follow up Visit and Imaging (PDF) *REV H March 2005*
• MammoSite RTS Registry - Case Report Form 4, page 1 - Adverse Events (PDF) *REV G July 2004*
• MammoSite RTS Registry - Case Report Form 4, page 2 - Adverse Events Definitions (PDF) *REV G 2004*