Minority patients are often underrepresented in clinical trials, data from which we derive our standard of care. Due to the underrepresentation of these patients, the clinical outcomes of treatments may be inappropriately extrapolated for these patients. Barriers to participation for minority patients include unconscious bias by medical practitioners, patient distrust of the medical enterprise, as well as language and medical literacy deficits. Ideally, clinical trials should aim for enrollment of ethnic composition that mirrors the proportion of patients affected by a particular cancer stage.
To address these deficits to equitable trial enrollment, we propose a supplementation of the traditional consent process to be tailored for the purposes of increasing minority enrollment. To this end, we propose to use video-based education tools using virtual-reality technology and to enhance our patient navigator program to increase minority recruitment an ongoing breast clinical trial. The use of virtual-reality videos will allow patients to see the environment in which they would receive treatment to reduce anxiety with an otherwise unfamiliar treatment such as radiation therapy.
We propose to employ the above recruitment strategies in an ongoing Phase I/II clinical trial aimed at investigating the safety and efficacy of concurrent cyclin-dependent kinase (CDK) 4/6 inhibitors with radiosurgery in women with advanced hormone receptor positive breast cancers with brain metastases. The goals of this study are to (1) improve minority clinical trial participation and to (2) improve the optimal communication strategies specific to this population that can be employed to help increase minority clinical trial enrollment.
Funded in partnership with the Kansas City Chiefs Football Club
Like smoking for lung cancer, infection by Helicobacter pylori (Hp) is the major risk factor for gastric cancer (GC). However, only <3% of those infected by Hp develop GC. We hypothesized that the interactions among Hp strains and/or between Hp and non-Hp microbes may affect their interaction with humans, therefore modify host clinical outcomes. We aim to find GC-associated microbial features that define the steps leading to GC. The results of this study will provide critical insights into the causes of GC. This study will also provide potential novel biomarkers to identify subjects at high risk or with early stage of GC, enabling interventions to reduce GC incidence and mortality.
Funded in partnership with the Lung Cancer Initiative of North Carolina, utilizing Stuart Scott Memorial Cancer Fund matching funds
Lung cancer causes more deaths than the next three cancers combined, and small cell lung cancer (SCLC) is the most aggressive type. Lung cancer disproportionally affects African Americans. Existing therapies prolong life, but only by months, and at the cost of substantial side effects. Within the immune system, T cells are particularly important for fighting cancer, but in patients with SCLC, neither the native immune system alone, nor with augmentation with existing immunotherapy, controls cancer durably. CAR-T is an exciting new technology that modifies a patient’s own T cells to recognize and attack cancer cells that bare a particular marker. This technology has revolutionized the care of some lymphomas and leukemias, including cures.
We have made a CAR-T for the treatment of Glioblastoma Multiforme because it bears a particular marker, GD2. 60% of SCLC also has GD2 and so we hypothesize that for these patients, GD2-directed CAR-T could provide dramatic tumor regression. Our cancer center has committed funding to a clinical trial if we can provide the necessary data to support it. More specifically, we would like to treat animal models of human SCLC with the proposed therapy to see if it is safe and effective. We would study where the CAR-T cells go and how well they kill cancer cells. The CAR-T contains a safety switch in case of side effects; we would test to make sure that it works. During the resulting human trial, we also seek funding to assess where the T cells go.
Black Americans often do not take part in research. They also have more aggressive breast cancer and a higher death rate from breast cancer. Overall, clinical trials have led to better outcomes for patients with breast cancer. However, the lack of Black Americans in clinical trials may be one explanation for higher death rates because new treatments are not tested in their aggressive cancers. Our goal is to help the community learn more about the role of research in breast cancer, and the value of taking part in that research. We will work with trusted members of the Black American community through our partners and lay Community Ambassador (CA) program to plan three forums. At these forums, community members will be able to talk with our doctors, clinical research coordinators, and CAs to learn about breast cancer, clinical trials, and what it means to take part in research. The forums will focus on breast cancer research. They will include questions from a host as well as questions from the audience. This will allow for an open discussion about breast cancer research. The goal of the forums will be to raise participants’ knowledge about research, and increase their odds of taking part in research.
Only a small percentage of patients with cancer in the US enroll on to clinical trials. This is creating a bottleneck for the development of new treatments. Efforts to improve how patients are identified for clinical trials are important to overcome this problem. One such effort which is showing promise is to use an individual known as a “pre-screener” to aid the clinical team in identifying eligible patients. The pre-screener functions as an extra set of eyes to review information generated from our electronic medical record as their records come in from referring physicians. They will be trained to look for patients meeting certain eligibility criteria and then notify the clinical team about the matches ahead of their visit. This will allow the team to better prepare and notify the coordinator for the study to be available at that time. The pre-screener will also serve as a resource for patients using our clinical trial education center in the clinic waiting area to help them navigate through the available information to identify a potential trial option to discuss with their physician during their visit.
The reasons why cancer patients do or do not participate in cancer (clinical trials) research are complex. Often this is due to the lack of awareness of which studies are occurring by both the patient and their primary care clinicians. Another very important reason is that patients, especially patients that do not speak English, are not invited to participate because the research team does not have non-English speakers or study materials in the patient’s language. We at the UC San Diego Moores Cancer Center (MCC) have the opportunity to better understand and address low clinical trials participation among our largest under-represented racial/ethnic group, Hispanics. Working with a multidisciplinary team of physicians and non-physician scientists, we propose to 1.) Educate community providers about breast cancer trials at MCC, and 2.) Assess specific interests and needs among the MCC breast cancer team, and combine this with existing evidence, including interview findings (knowledge and Hispanic from a recent (2016) V Foundation grant), to develop and implement minority clinical trial accrual training for the MCC breast cancer team. By focusing on minority breast cancer patients, V Foundation funds complement and expand our emerging efforts to increase minority clinical trials enrollment (accrual) and related outreach and inform how to intervene with MCC patients, providers, and leadership. We are particularly interested in targeting Hispanic breast cancer patients because they are the largest minority group in San Diego County, the region served by the MCC.
The Duke Cancer Institute and the College of Veterinary Medicine at N.C. State University formed a Comparative Oncology Consortium (COC), taking advantage of their expertise and national leadership in their respective disciplines and their geographic proximity. The goals are to collaborate in pre-clinical and clinical cancer research activities in order to advance our understanding of both cancer causation (a high incidence of specific cancers in specific dog breeds provides opportunities to identify new cancer susceptibility genes and environmental factors in cancer causation) and of behaviors and genetics of specific tumor types, as well as to coordinate clinical trials in humans and canines so that novel therapies can be tested in both settings, with information gained in one setting informing the other. In addition to response outcomes of these cancer therapies, the ability to use biomarkers and pharmacology in the canine models can be a novel addition to the characterization of these new cancer therapies and these insights could result in significant enhancements of clinical trial designs (including dosing, scheduling, and combination therapies) when these treatments are tested in human clinical trials. Cost savings and improved clinical trials design would help encourage pharmaceutical companies to use the canine models as part of the assessment process and would benefit the canine patients by giving them access to these novel therapies.
Funded in partnership with WWE in honor of Connor’s Cure
Medulloblastoma is the most common malignant brain tumor in children. There are four distinct forms of this tumor based on its gene profiles, and a form known as Group 3 medulloblastoma is the most aggressive and deadly, which accounts for 25%-30% of all medulloblastoma. Each medulloblastoma group has distinct abnormal gene expression that determines how it creates, grows, and spreads tumors. Changes in gene behavior, like overexpression or underexpression, are controlled by what is called epigenetics. Fortunately, we know how to manipulate epigenetics with drugs. Dr. Hu and his colleagues found two epigenetic components that play important roles in controlling gene expression in tumor. Interestingly, these two epigenetic components seem to work together: when one component is suppressed, the other increases, and vice versa. A gene called MYC is very active in many cancers including Group 3 medulloblastoma. In this project, Dr. Hu’s team will characterize these two epigenetic components to understand more precisely how they work, particular in controlling MYC expression, even further, they will test in the lab whether “drugging” these epigenetic factors can halt the growth and spread of medulloblastoma tumors. If this hypothesis is proven, it may be possible to use these drugs in combination to treat this devastating childhood cancer.
The goal of “Campaign to Improve Access to Clinical Trials” at The University of Arizona Cancer Center (UACC) is to increase the clinical trial access to a diverse population in Arizona. Dr. Pavani Chalasani, Breast Cancer Disease Oriented Team Leader, will oversee the campaign to improves access by involving the breast multidisciplinary team, patient navigators and physician liaisons to develop educational materials and outreach programs. Patients and community physicians will be targeted through proposed outreach programs by developing targeted educational materials. Materials and training will be provided to introduce and educate about clinical trials to patients early by various members of their cancer team. The goal of this campaign is to become a model for other disease teams and cancer centers to implement to improve clinical trial enrollment.
Multiple myeloma is a cancer of the blood and is the second most frequently diagnosed blood cancer in the US. Every year, about 30,000 patients are newly diagnosed, and about 12,000 die from this cancer. The main symptoms include anemia, bone pain, kidney failure, and infections. The most recent treatments have improved patient survival from about 3.5 to 5 years. Unlike some other blood cancers, myeloma still cannot be cured. Thus, the development of new drugs and treatments is essential. The purpose of our study is to understand how an understudied class of genes, called long noncoding RNA genes (lncRNAs), participates in the development of multiple myeloma and may be used to develop entirely new treatments. Specifically, we propose innovative approaches to investigate a specific lncRNA gene, MALAT1 (metastasis-associated lung adenocarcinoma transcript 1) and how it functions in the repair of damaged DNA to promote the initiation and progression of multiple myeloma. We recently discovered that the MALAT1 gene is involved in an alternative DNA repair network that has seldom been studied in multiple myeloma. We believe that MALAT1 modulates the transition to advanced myeloma and myleoma that occurs outside the bone marrow. Our fundamental goal is to establish how MALAT1 regulates the repair of DNA damage and therefore its functional significance in multiple myeloma initiation and progression. This entirely novel knowledge will open new avenues for patient therapy and ultimately improve patient outcomes.
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