Clinical Trial ID:
Prospective Registry of Breast Cancer Patients with Axillary Nodal Metastases Identified During Ultrasound Staging at MD Anderson Cancer Center - PA11-1087
Description
Prospective Registry of Breast Cancer Patients with Axillary Nodal Metastases Identified During Ultrasound Staging at MD Anderson Cancer Center
Objective
1. To prospectively identify patients with axillary nodal metastases documented by routine percutaneous biopsy (FNA and/or core) undergoing standard nodal ultrasound
2. To collect information about the effect of neoadjuvant chemotherapy on the individual nodes that had documented metastases that will allow us to evaluate that information in future research.
3. To create a prospective registry that will allow us to develop alternatives to
routine axillary lymph node dissection in these patients through future research.
Treatment
Describe provisions taken to maintain confidentiality of specimens/data:
Data will be stored in a locked office or on a password-protected database on a password-protected
and/or encrypted computer behind a firewall.
Describe the security plan for data including where data will be stored, how long the data will be stored and what will be done with the data once the study is terminated. If the data will be used for future research, please explain.
Data will be stored in a locked office or on a password-protected database on a password-protected and/or encrypted computer behind a firewall. No one will be allowed access to the data without an IRB-approved protocol.
Data will be stored forever, and may be used for future protocols with IRB approval
Please describe how you will protect the subject’s identity:
Only PI and relevant research staff will have access to linking information. All linking information will be stored in a password protected, encrypted computer inside secured firewall.
Main Investiagtor
Lesnikoski, Beth
Participating Institutions
Baptist MD Anderson Cancer Center; Baptist MD Anderson Cancer Center GOS
Eligibility
Breast cancer patients undergoing routine percutaneous image guided documented
axillary node metastases in where a clip was placed between 11/7/11 to 12/23/2021.
Secondary Trial ID Number
PA11-1087/CLIP