The research samples will contain labels on the blood tubes that have the patient's initials, date of birth, the assigned protocol, and the date the sample was drawn. The transmittal forms accompanying th e samples also contain the same information. Once a patient ’s treatment schedule has been determined, it should be faxed to Sandra Doren at the Laboratory of Tumor Immunology and Biology/ NIH (Fax: [301] 496-2756; phone: [301] 496-9573) for planning purposes. 5.1.2 Brachyury expression in tissue samples • Upon enrollment, a minimum of 3- 4 unstained slides, preferably from a metastatic site of disease, will be requested for analysis of brachyury expression. Unstained slides from the primary will also be requested, if available. This is not required for enrollment and will be analyzed retrospectively. • An optional on-study biopsy will also be presented as a means to obtain pathologic samples for correlation of clinical outcomes with Brachyury expression. 5.2 S AMPLE STORAGE , TRACKING , AND DISPOSITION Samples will be ordered and tracked through the CRIS Screens. Should a CRIS screen not be available, the NIH form 2803- 1 will be completed and will accompany the specimen and be filed in the medical record. Samples will not be sent outside NIH without IRB notification and an executed MTA. 5.2.1 Samples Sent to Clinical Services Program (CSP) All data associated with patient samples are protected by a secure database. All samples drawn at the NIH Clinical Center will be transpo rted to the NCI Frederick Central Repository by Leidos couriers. Samples will be tracked and managed by the Central Repository database. All samples will be stored in liquid nitrogen. These freezers are located at NCI Frederick Central Repository in Freder ick, Maryland. Fisher BioServices manages the NCI Frederick Central Repositories under subcontract to Leidos Biomedical Research, Inc. , Frederick. NCI Frederick Central Repositories store, among other things, biological specimens in support of NIH clinical studies. All specimens are stored in 40 Abbreviated Title: Phase I MVA -Brachyury -TRICOM Version Date: September 14, 2016 Confidential secure, limited access facilities with sufficient security, back -up and emergency support capability and monitoring to ensure long- term integrity of the specimens for research. Specimens are stored in accordance with applicable H HS and FDA Protection of Human Subjects Regulations in accordance with Fisher BioServices Federal -Wide Assurance. Fisher BioServices’ role is limited to clinical research databases and repositories containing patient specimens. Fisher BioServices neither conducts nor has any vested interest in research on human subjects, but does provide services and supports the efforts of its customers, many of which are involved in research on human subjects. The Fisher BioServices IRB reviews policies and procedures for labeling, data collection and storage, access, and security. The IRB will review protection of privacy issues prior to acceptance of any new work and in the event of change impacting privacy issues in existing work. It is the intent and purpose of Fisher BioServices to accept only de-identified samples and sample information. To the bes t of our ability, every effort will be made to ensure that protected information is not sent electronically or by hard copy or on vial labels. Sample data is st ored in the BioSpecimen Inventory (BSI) System II. This inventory tracking system is used to manage the storage and retrieval of specimens and to maintain specimen data. BSI is designed for controlled, concurrent access. It provides a real- time, multi- user environment for tracking millions of specimens. The system controls how and in what order database updates and searches are performed.