The NCRR awarded the CTRI two one-year funding supplements of $500,000 each on September 1, 2011. One of the funded project focuses on the genomics of breast cancer and the other project looks at increasing community engagement in clinical research in 4 specific community groups.
The project summaries are listed below:
- Kelly Frazer, PhD
Abstract: The application of genomic sequence data for routine clinical cancer care is at the cusp of feasibility. Here we propose to develop within the Moores UCSD Cancer Center and the UCI Chao Family Cancer Center ultra-deep targeted sequencing (UDT-Seq) of cancer genes to guide the care of cancer patients. A growing number of somatic mutations in cancer genes are proven biomarkers predicting sensitivity or resistance to therapy. Current assays to detect somatic mutations are not comprehensive. The overall objective of this project is to leverage the emerging technology of targeted high-throughput sequencing to implement an assay that can reliably detect somatic mutations in a panel of clinically relevant genes without arduous sample requirements. This assay could be used to improve the selection of adjuvant and metastatic treatments, in both clinical trials and clinical care. The UDT-Seq assay is cost-effective and capable of detecting somatic mutations that are present in as few as 1% of tumor cells. Specifically we will perform UDT-Seq of ~50 cancer genes in each tumor. We have piloted this approach with RainDance Technologies (a microfluidic company) to develop a streamlined sample preparation to facilitate clinical implementation with next-gen sequencing. Going forward we will update the sequencing platform to the new Ion Torrent (Life Technologies) instrument: its low cost and 2.5 hr run time will further accelerate the clinical implementation of the UDT-Seq assay. For this project we will assay tumor samples from 40 subjects with resectable breast cancer who are enrolled in the UC-wide ATHENA Breast Health Network. When possible assays will be run on germline, the primary tumor and on lymph node metastases to generate novel data on the clonal evolution of actionable mutations. These data will enable future work on adjuvant therapy to target rare subpopulations of cancer cells predisposed to metastatic recurrence. During the project period we will plan a master trial of metastatic solid tumors using UDT-Seq to guide the testing of targeted agents in cancers from differing sites of origin, potentially altering the paradigm of cancer treatment. Our UCSD and UCI teams will leverage the strong UC-wide ATHENA collaboration to include the five UC medical centers in future trials.
Project Director -
Howard Taras, MD
Abstract: A major goal of the Clinical Translation Research Institute (CTRI) at University of California-San Diego (UCSD ) is to enhance enrollment in clinical trials and increase the trials' successful completion. This will accelerate the translation of research to the availability of safe, effective, and novel drugs, devices, and diagnostic tools. To achieve this goal, the proposed projects aims to (1) make many more individuals aware of clinical trials (particularly those who suffer from health disparities), (2) understand and overcome logistical barriers to participation that face many populations, and (3) shape the understanding that community members have of research so that there is basic trust in science, scientists, and clinical trials in particular.
The methods to achieve these aims are based on the premise that community-based organizations ("agencies") serve and represent different constituencies of the general population and are ideal venues to reach many sub-populations that comprise the general public. Community agencies are created and thrive because they are trusted by the portion of the public they serve; because they provide resources that are useful to their clientele; and because often leadership are, themselves, members of the very community they serve. As a proof of principle that agencies can endorse promotion of clinical trials to their clientele and adopt this as a permanent role, we propose to engage four local agencies that represent different kinds of populations (persons with epilepsy, rural population, veterans, and Asian-Pacific Islanders). Methods: The project will begin with bi-directional conversations between CTRI leaders and community agency leaders, and be followed by reaching community members themselves through focus groups and through hosted interactive social and educational events that spotlight clinical research. One tangible outcome of the proposal will be tailored recruitment materials and strategies that clinical investigators can use (tailored to be appreciated and understood by potential human subjects). Another outcome will be novel community agency policies and practices that are designed to promote research participation to their clientele and designed to maintain a bidirectional communication and partnership with CTRI.
Learn more about the CTRI Mission
About UC San Diego Altman Clinical and Translational Research Institute:
UC San Diego Altman Clinical and Translational Research Institute (ACTRI) is part of a national Clinical and Translational Science Award consortium, led by the National Institutes of Health National Center for Advancing Translational Science. Established in 2010, ACTRI provides infrastructure and support for basic, translational and clinical research throughout the San Diego region to bring discoveries from the laboratory to the bedside, and facilitates training and education of the next generation of researchers. ACTRI carries out its activities in collaboration with institutional and corporate partners and currently has more than 1,425 members.