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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 |
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 | 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 | PINK (SH-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 |
Scripps Translational Science Institute
| Trial Name | The Biorepository for Scripps Health |
|---|---|
| Acronym | BIF |
| ClinicalTrials.gov Identifier | NCT01006239 |
| Primary Investigator | Eric J. Topol, MD |
| Sponsor | Scripps Translational Science Institute |
| Status | Recruiting |
| Description | Biorepository samples will be utilized in a variety of research studies intended to help in the diagnosis and/or treatment of patients, including the possible identification of therapeutic targets or genetic identifiers of cancers and possibly other diseases. Various technologies including gene expression, genotyping, DNA and RNA sequencing, protein and metabolite analysis may be used in the course of the various studies An exemplary project currently under consideration is one in which Scripps Genomic Medicine is comparing the DNA sequence of both a patient's tumor and their germline DNA to identify genetic differences between the two. These differences could help identify specific pathways that are regulating the tumor and disease thus leading to potentially valuable information in how to treat that individual patient as well as other patients with similar genetic characteristics. In addition, differences between the tumor and germ-line observed in multiple patients could help identify therapeutic targets that are cancer specific. A secondary exemplary project which is currently underway is one in which Scripps Genomic Medicine is undertaking RNA sequencing to identify "fusion genes" which are hybrid genes formed from two previously separate genes and are a type of genetic mutation that has been identified in certain types of cancers including those of the prostate and breast and certain forms of leukemia. Identifying new fusion genes could provide valuable insights into both treatment protocols and new therapeutic targets. The goal of this project is to expand and improve the bio-repository already established within the Scripps Genomic Medicine (SGM) group. Presently, the collection has been focused on the collection of predominately prostate tumors and blood as the corresponding normal tissue. The current collection is annotated with pathology information and limited medical information collected from the patient during the consenting process; no post surgical information is collected. We believe that collection can be enhanced by (i) modifying the tumor collection process, (ii) simplifying the means of consenting the patients such that it relies upon the general surgical consent and (iii) using de-identified medical data already consolidated in the Cancer registry as a means of annotating the tissue samples. |
| Enrollment Contact |
Sharon Haaser, RN .(JavaScript must be enabled to view this email address) (858) 554-5758 |
| Trial Name | Molecular and Morphologic Characterization of Circulating Endothelial Cells | |
|---|---|---|
| Acronym | CEC | |
| ClinicalTrials.gov Identifier | NCT01005485 | |
| Primary Investigators | Eric J. Topol, MD; Sarah Shaw Murray, PhD | |
| Sponsor | Scripps Translational Science Institute | |
| Collaborators | The Scripps Research Institute, Palomar Memorial Hospital, Scripps Green Hospital and Clinic, Sharp Memorial Hospital, Sharp Grossmont Hospital | |
| Status | Recruiting | |
| Description |
Circulating endothelial cells (CECs) have been shown to be readily detectable in patients with acute coronary syndromes and appear to be remarkably predictive of an impending arterial catastrophe (heart attack or stroke). Even though these cells were discovered a decade ago, to date there has not been any work to characterize them more fully with definition of ultrastructure, whole genome sequencing, gene expression, methylation and histone modification. Since coronary arterial biopsy is not possible in live patients, CECs provide an extraordinary window into spontaneous arterial disruption and serve as a fluid-phase biopsy. This project coalesces the trans-disciplinary efforts of three NIH-supported teams with synergic capabilities.
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| Enrollment Contact |
Sarah Topol, RN .(JavaScript must be enabled to view this email address) (858) 554-5747 |
Sharon Haaser, RN .(JavaScript must be enabled to view this email address) (858) 554-5758 |
Scripps Advanced Clinical Trials
| Trial Name | Maintenance of Platelet Inhibition With Cangrelor After Discontinuation of Thienopyridines in Patients Undergoing Surgery: The BRIDGE Trial |
|---|---|
| Acronym | BRIDGE |
| ClinicalTrials.gov Identifier | NCT00767507 |
| Primary Investigator | Eric J. Topol, MD |
| Sponsor | The Medicines Company |
| Collaborators | Scripps Advanced Clinical Trials (SACT), Scripps Genomic Medicine |
| Status | Recruiting |
| Description | Cangrelor (formerly denoted as AR-C69931MX) is a short-acting, potent, competitive P2Y12 platelet receptor antagonist. P2Y12 receptors are highly expressed on the surface of platelets and cangrelor is specific for this receptor. Cangrelor is currently being investigated as an investigational antiplatelet agent to enable safe bridging of patients undergoing surgery. The purpose of the study is to demonstrate that a cangrelor infusion will maintain levels of inhibition of aggregation >60% as measured by Accumetrics VerifyNow P2Y12 assay in over 80% of the samples in patients needing coronary artery bypass grafting (CABG). This level is the equivalent to those levels expected to be maintained if a thienopyridine (clopidogrel or ticlopidine) had not been discontinued. |
| Enrollment Contact |
Judith Sheard, MPH, CCRA .(JavaScript must be enabled to view this email address) (858) 554-5741 |
| Trial Name | Gauging Responsiveness With a VerifyNow Assay – Impact on Thrombosis and Safety |
|---|---|
| Acronym | GRAVITAS |
| ClinicalTrials.gov Identifier | NCT00645918 |
| Primary Investigator | Matthew J. Price, MD |
| Sponsor | Accumetrics |
| Collaborators | Scripps Advanced Clinical Trials (SACT), Scripps Genomic Medicine |
| Status | Active, no longer recruiting |
| Description | The inhibitory response to clopidogrel varies widely among individuals. Data suggest that patients with high residual platelet reactivity despite clopidogrel therapy are at greater risk for thrombotic events after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). The Gauging Responsiveness with A VerifyNow assay--Impact on Thrombosis And Safety (GRAVITAS) trial is designed to evaluate whether tailored clopidogrel therapy using a point-of-care platelet function assay reduces major adverse cardiovascular events after DES implantation. The objective of the GRAVITAS trial is to determine whether tailored anti-platelet therapy using the Accumetrics VerifyNow P2Y12 assay reduces major adverse cardiovascular events after drug-eluting stent implantation. GRAVITAS is an international, randomized, multicenter, double-blinded, placebo-controlled, clinical trial. Approximately 2,800 patients with stable angina/ischemia or non-ST-elevation acute coronary syndrome undergoing PCI with DES will be enrolled. Patients with high residual platelet reactivity on clopidogrel therapy 12 to 24 hours post-PCI will be randomized to standard maintenance clopidogrel therapy (75 mg daily) or high-dose clopidogrel therapy (additional loading dose followed by 150 mg daily) for 6 months. A random sample of patients without high residual reactivity will be followed and treated with standard clopidogrel therapy for 6 months. The primary end point is the time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or definite/probable stent thrombosis. Platelet function analyses will also be performed at 30 days and 6 months. |
| Enrollment Contact |
Judith Sheard, MPH, CCRA .(JavaScript must be enabled to view this email address) (858) 554-5741 |
| Trial Name | Genotype Information and Functional Testing Study (A Sub-study of GRAVITAS) Trial |
|---|---|
| Acronym | GIFT |
| ClinicalTrials.gov Identifier | NCT00992420 |
| Primary Investigator | Matthew J. Price, MD |
| Sponsor | Bristol Myers Squib, Sanofi-Aventis, Accumetrics, Inc |
| Collaborators | Scripps Advanced Clinical Trials (SACT), Scripps Genomic Medicine |
| Status | Recruiting |
| Description | GIFT is a substudy of GRAVITAS and is designed to examine the genetic determinants of the level of RPR after clopidogrel treatment, and in turn, the genetic determinants of high RPR ("non-responsiveness") in patients undergoing platelet function testing in GRAVITAS. The study is also designed to determine, within the cohort of randomized GRAVITAS patients, the effect of these genetic determinants on the change in RPR with an increased maintenance dose. GRAVITAS (Gauging Responsiveness with A VerifyNow assay--Impact on Thrombosis And Safety) is a multicenter, randomized clinical trial that will screen approximately 6,000 patients with a blood draw to enroll approximately 2800 patients. The trial will examine (1) whether increasing the dose of clopidogrel to 150-mg/day in patients with high residual platelet reactivity (RPR) after percutaneous coronary intervention (PCI) with drug-eluding stent (DES) implantation based on the Accumetrics VerifyNow P2Y12 assay will reduce the hazard rate for ischemic events; and (2) whether patients with high RPR treated with the standard clopidogrel 75-mg/day will have a greater hazard rate for ischemic events than similarly treated patients without high RPR. We hypothesize that (1) reduced CYP and drug-efflux transporter polymorphisms will be significantly associated with the level of RPR on standard clopidogrel therapy and with the incidence of high RPR (residual platelet reactivity ≥ 230 PRU); and (2) these alleles may influence the change in reactivity when patients with high RPR are treated with increased clopidogrel dosing (clopidogrel 150-mg/day). |
| Enrollment Contact |
Judith Sheard, MPH, CCRA .(JavaScript must be enabled to view this email address) (858) 554-5741 |
West Wireless Health Institute
External Collaborations
| Trial preparation in progress |
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| Trial Name | Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance |
|---|---|
| Acronym | CHARISMA |
| ClinicalTrials.gov Identifier | NCT00050817 |
| Primary Investigator | Eric J. Topol, MD (at Scripps Health) |
| Sponsor | Sanofi-Aventis |
| Collaborator | Scripps Health, Scripps Advanced Clinical Trials (SACT) |
| Status | Completed |
| Description | Atherothrombosis is a progressive and generalized vascular disease resulting in events leading to myocardial infarction (heart attack), stroke, and vascular death. In patients at risk for this disease, it is characterized by an unpredictable, sudden disruption of atherosclerotic plaques, which may lead to total occlusion of artery due to formation of a clot. The use of aspirin (blood thinner agent) for reducing those major ischemic events is either indicated, or recommended by international guidelines. However, aspirin fails to prevent a high percentage of such life-threatening events. Therefore, more effective blood thinning therapy may provide additional clinical benefit to such patients. The results of the CURE trial in patients with unstable angina demonstrate the additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood thinner agent), when administered in combination with standard therapy including aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of clopidogrel may apply to a broad population of high-risk patients receiving low-dose aspirin therapy. Such population includes patients with previous cardiovascular, neurovascular or peripheral arterial manifestations of atherothrombosis and patients with combinations of recognized risk factors for atherosclerosis. |
| Enrollment Contact | Enrollment is closed at this time. |
| Trial Name | Comprehensive Rimonabant Evaluation Study of Cardiovascular Endpoints and Outcomes |
|---|---|
| Acronym | CRESCENDO |
| ClinicalTrials.gov Identifier | NCT00263042 |
| Primary Investigator | Eric J. Topol, MD (at Scripps Health) |
| Sponsor | Sanofi-Aventis |
| Collaborator | Scripps Health, Scripps Advanced Clinical Trials (SACT) |
| Status | Terminated by Sponsor |
| Description | CRESCENDO is a phase III international, randomized, multicenter, double-blinded, placebo-controlled, clinical trial. Approximately 18,000 patients with a history of myocardial infarction (MI, heart attack), symptomatic coronary artery or peripheral arterial disease, or ischemic cerebrovascular episode (stroke or TIA) will be enrolled. Patients will be randomized to placebo or rimonabant (SR141716) daily dose (20 mg) therapy. The primary objective is to show whether rimonabant reduces the risk of a heart attack, stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors. The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients. Protocol: CRESCENDO Protocol |
| Enrollment Contact | Enrollment is closed at this time. |
