The Molecular Core is a new service designed to specifically address the molecular assays required for the successful completion of the Program Project. The main objective is to provide a centralized facility for procurement, processing, and storage specimens for nucleic acid isolation, recombinant protein production, and molecular marker assessment of bloods related to the Multicenter Phase II and III trials. The Phase III polyvalent melanoma cell vaccine (PMCV) multicenter trial is an invaluable source for procurement of blood and tumor tissues for molecular analysis in this proposal and future studies. To ensure the integrity of samples and the meaningfulness of analysis, it is crucial that there is centralization of the operation so that stringent standards operating procedures (SOPs) of specimen handling, processing, cryostorage, and cataloging can be implemented. The designated molecular core facility will function as the center for these multiple task operations. One of the major efforts of the core will be to undertake the multimarker RT-PCR analysis of circulating tumor cells from serial bleeds obtained from patients participating in the Phase III PMCV trial. Prospectively collected blood from patients entered in the trial will be used for the RT-PCR assay to evaluate the prognostic utility of molecular surrogate markers. In addition, the core will perform RT-PCR assays of serial bleeds from the Phase II clinical trials proposed. Archived paraffin-embedded tumor tissues will be procured from patients entered into the trial from different centers for both RNA and DNA analysis. Another major task of the core will be to produce recombinant melanoma-associated antigens (MAA) proteins for assessment of patients' antibody and cellular immune responses to specific MAAs. In addition to supporting the Program Project, the core will also provide procurement and processing of valuable specimens from the Phase III clinical trial for future molecular studies.
Showing the most recent 10 out of 238 publications
