Scripps Translational Science Institute

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Scripps Advanced Clinical Trials

The Scripps Advanced Clinical Trials program capitalizes on the latest in genetic technology. Genetic data is used to identify potential research opportunities for highly targeted clinical trials to expedite the translation of laboratory discoveries to patient care.

In collaboration with pharmaceutical, medical device, biotechnology and medical diagnostic companies, Scripps Health is reinventing the nature of clinical trials. Instead of broadly testing 10,000 people through a scatter approach, Scripps uses individual genetic data, to target small groups of 500 or less who share a particular gene variant.

Scripps Advanced Clinical Trials bring the promise of genetic discovery full circle. Genetic data are used to identify potential research opportunities, which lead to highly targeted clinical trials and a shorter time between laboratory discoveries and their application in patient care. This elegant matching of an individual’s genetic makeup with precise, gene-based medications and devices will lead to treatments that are generally safer and more effective than what is common practice today.

For more information: video of Judy Sheard, M.P.H., Senior Project Manager, Scripps Advanced Clinical Trials.

With the infrastructural support provided by the CTSA Consortium, research at STSI is a truly collaborative effort between STSI, Gary & Mary West Wireless Health Institute, Scripps Advanced Clinical Trials, Scripps Genomic Medicine, and external collaborators. Our current research and clinical trials are described for each institute listed below.

Scripps Genomic Medicine | Scripps Translational Science Institute |

Scripps Advanced Clinical Trials | West Wireless Health Institute |

External Collaborations

Scripps Genomic Medicine

Trial Name	Genomic Investigation of Cardiovascular Diseases
Acronym	GeneHeart
ClinicalTrials.gov Identifier	NCT00722748
Primary Investigator	Eric J. Topol, MD
Sponsor	Scripps Health, Scripps Genomic Medicine
Collaborator	Scripps Translational Science Institute
Status	Active, no longer recruiting
Description	Cardiovascular disease (CVD) remains the major source of morbidity and mortality in developing countries, and is fast reaching the same status in the underdeveloped countries. The pathophysiology of CVD is gradually being elucidated and we are constantly discovering new underlying cellular and molecular defects that lead to disease. The completion of the Human Genome Project has added a new dimension to this growth, allowing researchers to examine the role of genetic mutations in individual genes in regard to their role in causing CVD. The GeneHeart trial puts forward a research plan to initiate a genetic databank, henceforth referred to as The Genebank at Scripps Clinic Registry. This database will usher in genomic research at Scripps as we strive to stay at the forefront of cardiovascular research in the new century. The objective of this study is, to obtain blood samples in order to define genes for various cardiovascular conditions. The blood samples will undergo DNA analysis to search for up to 1 million SNP's per individual, in the hopes of identifying genetic expression patterns which explain not only the onset and development of CVD, but also the variability of disease manifestations between individuals and the response to drug treatment.
Enrollment Contact	Enrollment is closed at this time.

Trial Name	Study to Detect Genes Responsible For the Development of Solid Tumors of the Prostate and Colon
Acronym	GIST
ClinicalTrials.gov Identifier	NCT01005225
Primary Investigators	James Mason, MD
Sponsor	Scripps Health
Collaborators	Scripps Green Hospital, Scripps Memorial Hospital
Status	Active, no longer recruiting
Description	This research is to learn more about DNA differences that are linked to the formation of solid tumors. Requires one 30 minute visit with a study nurse who will review health questions and draw a blood sample. A tissue sample of the tumor will also be collected at the time of your surgery.
Enrollment Contact	Sharon Haaser, RN .(JavaScript must be enabled to view this email address) (858) 554-5758

Trial Name	Scripps Polster Breast Care Center Investigational GeneBank Trial
Acronym	PINKSH-PINK Study
ClinicalTrials.gov Identifier	NCT00945464
Primary Investigator	Eric J. Topol, MD
Sponsor	Scripps Health, Scripps Polster Center
Collaborator	Scripps Translational Science Institute
Status	Active, no longer recruiting
Description	Breast cancer is a disease of complex origin with a strong genetic component. The incidence of breast cancer is very high in monozygotic twins of patients, and it is thought that a high proportion and perhaps the majority of breast cancers arise in a small number of genetically susceptible women. Recent studies in human genetics have discovered several intervals in the human genome containing inherited variants that are statistically associated with the propensity to develop breast cancer. The investigators plan to use this knowledge to design a genetic screening test to guide recommendations for breast cancer screening with mammography. If the small group of genetically susceptible women can be identified, more effective breast cancer screening strategies can be implemented. In contrast, a very large proportion of women who undergo yearly mammography are at exceptionally low risk from a genetic perspective. Using genomic guidance could eventually reconfigure the most efficacious strategy to screen women for early detection of breast cancer. By developing a genetic screening panel based on genetic markers for breast cancer, the investigators will be able to more accurately determine a woman's individual risk for developing breast cancer.
Enrollment Contact	Enrollment is closed at this time.

Trial Name	Scripps Genomic Health Initiative
Acronym	SGHI
ClinicalTrials.gov Identifier	NCT00808587
Primary Investigator	Eric J. Topol, MD
Sponsor	Scripps Health, Scripps Genomic Medicine
Collaborator	Scripps Translational Science Institute; Navigenics, Inc.; Affymetrix, Inc.; Microsoft Corp.
Status	Active, no longer recruiting
Description	The specific aims for this project are to enroll up to 10,000 subjects who will have their genomes surveyed using the Navigenics™ Health Compass technology. The Navigenics Health Compass helps you understand what your genetic variants have to say about the future of your health, and gives you action steps to take control of your health today. In addition, the investigators will assess how the Navigenics Health Compass, results affect lifestyle decisions. The phenotyping information that can be analyzed with the resulting Navigenics genotype information will assist in identifying genetic variations associated with other traits and diseases. The uses of molecular markers such as cholesterol and glucose levels to assess disease risk are well established in clinical medicine today. Although these tools are useful in screening for subclinical disease, their predictive value is limited. Until recently, these molecular markers were the best risk assessment and screening tools in existence. Since the completion of the Human Genome Project, the era of personalized medicine, which exploits knowledge of the genes an individual carries that may predispose him/her to disease, has come to the forefront of research. The Navigenics Health Compass technology assesses risk for about over 20 common diseases and provides subjects with more accurate assessments of their individual predictive risk for developing these conditions than traditional biomarkers such as cholesterol and glucose levels. This may positively influence changes in lifestyle, as well as decisions to seek further medical evaluation associated with preventive strategies.
Enrollment Contact	Enrollment is closed at this time.

Trial Name	The Healthy Elderly Longevity Cohort
Acronym	Wellderly
ClinicalTrials.gov Identifier	NCT01004133
Primary Investigators	Eric J. Topol, MD
Sponsors	Scripps Health, Scripps Translational Science Institute
Status	Recruiting
Description	With the completion of the human genome project, investigators can now explore new questions in human biology. Previously human genetics focused on highly penetrant, Mendelian traits; however, now rare and common variants can be discovered that affect "common" diseases that have multi-gene architecture with variable penetrance such as breast cancer, diabetes mellitus, and coronary artery disease. This change took place because investigators now have the tools to illuminate the whole genome at once to discover the genetic variants responsible for different disease phenotypes through statistical differences between populations. Besides disease phenotypes, health can be considered a human phenotype that can be studied. Health is not merely the absence of disease but may be viewed as a dynamic ongoing interplay between the environment and the genome to maintain homeostasis. Individuals often attempt to optimize environmental conditions according to ones genome to maximize their health. All individuals possess potentially beneficial and harmful variants depending on the environment. How this dynamic interplay occurs between the genome and environment requires understanding the boundary conditions of the genetic architecture of health and disease and then modeling the system to simulate the observed data. The aging process also affects health. Aging involves a loss of the normal coping responses to internal and external environmental stressors or signals. Investigators now have the tools to uncover from the bottom up the mechanisms involved in maintaining the ability to overcome environmental conditions that can affect health. Against this genomic breakthrough of whole genome association studies, the demographics in the United States are quickly changing. The older population (age > 65 years) in 2030 is projected to be twice as large as in 2000 representing nearly 20 percent of the total US population. The first baby boomers turn 65 in 2011 and will challenge all facets of health care in the coming decades. The demographic changes underscore the need to understand the mechanisms that promote health and disease in this cohort. Genomic discoveries will help individuals and may reduce medical costs and benefit society. In summary, the objective of this study is to obtain blood and/or saliva samples in order to help model health and disease phenotypes through population genomics. The blood and/or saliva samples may allow for participants' entire genomes to be sequenced if such comprehensive analysis becomes feasible and economical. More information on qualification criteria can be found at the Scripps Health Wellderly website (SH-Wellderly Study).
Enrollment Contact	Sarah Topol, RN .(JavaScript must be enabled to view this email address) (858) 554-5747