Funded in partnership with the Goldberg Family Foundation and in collaboration with the Gray Foundation
Individuals with BRCA1 or BRCA2 mutations have an increased risk of developing breast, ovarian, pancreas, prostate and other types of cancer. Tumors arising in these individuals are often sensitive to PARP inhibitors (PARPi) and this class of drugs has shown remarkable success in the treatment of BRCA1 and BRCA2-mutant tumors. Despite these successes, tumors frequently become resistant to therapy. Using functional genomic approaches, we will investigate mechanisms of resistance and identify novel genetic vulnerabilities that can be exploited by PARPi treatment. We will also investigate the immune response to BRCA-mutant tumors and explore ways to improve the ability of immune cells to recognize and kill these tumors. The ultimate goal of these studies is to improve outcomes for patients with BRCA-mutant tumors and to identify new groups of patients that can benefit from PARPi.
African Americans have the highest percentage of new cancer cases in the United States and the worst outcomes. Some people die from cancers that can be prevented or treated, simply because they are not aware of all of the treatment options. Cancer care can be very difficult because many times a patient has more than one doctor who is part of their care team. This can be scary and may make some people choose not to get cancer treatment, even if they can be cured. Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) wants to make sure that everyone has access to the best cancer care possible. To meet that goal, we will engage an African American Patient navigator (AAPN) – someone who is from the community who can help people learn about cancer, how to prevent it, what screening is required and what treatments are available. If someone diagnosed with cancer comes to WFBCCC for treatment and needs assistance, the AAPN will meet with them and work to help remove any barriers to care. The AAPN will also talk about clinical research that may be recommended as part of a treatment plan. Cancer research may improve outcomes for them or it may provide information that can help improve treatments for the next generation of cancer patients. Since African Americans get cancer more often, it is important to make sure they are represented in studies that look at new treatments and supports for cancer patients.
Clinical trials are important to improve cancer treatments and survival. Very few people are treated on cancer clinical trials and an even small number of those treated on a trial are African American. One way to solve this problem is to use specially trained staff to help cancer patients better understand clinical trials. These staff are called patient navigators. In this project, we will use patient navigators, one who is African American, to teach and support patients asked to be in cancer clinical trials. These navigators will work as a team to make sure that all African Americans who receive care at the Cancer Center are considered for cancer clinical trials. They will teach patients about clinical trials. They will also help them better understand the hospital system and give advice to patients who live far away and don’t have a car or place to stay when they come to their appointments. They can connect patients to finance counselors, social workers and other helpful community
services. To understand if the project is a success, we will compare the total number of patients, by race, treated on cancer clinical trials before and after the project. We will also study why patients chose not to be on clinical trials even when they are eligible. This information will help us design new projects in the future.
There is a low number of people involved in clinical studies. This is a national problem. This problem plays a part in poor health for people with cancer. It is even more of a problem for people of color who do not take part in clinical studies at the same rate as whites for several reasons. Some of these reasons include fear and not knowing about clinical studies. Also, some current and past research studies did not tell people of color the truth about the study and caused high rates of sickness and death in some cases. These reasons play a role in some people deciding not to take part in a study. Some people of color are not involved with clinical studies because they were not asked. Research teams may not ask people of color due to bias that they may not be aware of or concerns about trust. Studies show that most people who take part in a study do so because they were asked. The main reason people do not enroll in clinical studies is because they were not asked and did not know anything about it.
Studies suggest there is a need to teach research teams how to build skills in working with people of color. There is a need to build trust between patients and clinical staff as well as learn ways to increase the number of people of color enrolled in studies. The Just Ask: Diversity in Clinical Research Training Program works with patients, the community, and research teams to build skills and increase the number of people of color in clinical studies.
The healthcare landscape has dramatically changed in South Florida, and we welcome you to be a partner in this transformation. Miami Cancer Institute at Baptist Health South Florida opened its doors in 2016 and is now seeing nearly 1,000 patients per day. The Institute, supported by a clinical and research alliance with Memorial Sloan Kettering, one of the leading academic cancer centers in the world, grants our patients access to the most advanced clinical trials for breast cancer. Patient accrual remains a huge challenge in clinical research, and the grant will go towards supporting recruitment for the important studies which in many cases, may give patients access to new therapies that are not yet readily available. The Institute will be proactive with the creation of recruitment materials as part of a well-coordinated campaign to address all aspects of enrollment as well as presenting information in an easy to understand and honest way. It is our goal to track enrollment efforts and adjust accordingly to what works best for our patient base and the community we serve. The mission of the breast clinical trial enrollment program is to provide innovative, patient centered cancer care through access to cutting edge treatment.
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.
