As a patient at Winship, you have access to some of the world's leading myeloma experts and to a healthcare team that provides the highest standard of care, the newest clinical trials available and the most up-to-date approaches in managing myeloma. Johns Creek, Georgia 30097, 5665 Peachtree Dunwoody Road, NE Atlanta, Georgia 30342, 615 Peachtree Street NE Stratification factors include tumor stage . Despite its high prevalence, Black patients only comprised 1.8% of the clinical trial population of a promising trial conducted in 2015. The best choice is an educated choice. The form is designed in such a way that a completed form will provide the regulatory department with all the information needed for IRB submission, and concurrent submission to the PRMC and IRB is required. Clinical trials are scientifically reviewed and approved by an Internal Review Board, as well as by sponsors or the National Cancer Institute. Clinical Research Training. It is these extra eyes that provide not only additional oversight, but also additional safety for patients while they are on clinical trials. The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy. Call us at (888) 828-2206. "Winship is thrilled to appoint Dr. Harvey to this critical role. To conduct a 12-month RCT of a high legume, high fiber diet (HD) vs. control (healthy American) diet in middle-aged participants with an increased risk of colon cancer, and to measure its ability to reduce body weight and favorably impact biomarkers associated with colon cancer risk. Lithonia, Georgia 30058, Winship Cancer Institute of Emory University, Winship Cancer Institute of Emory University, Winship Cancer Institute at Emory Midtown. Kim Nguyen, BS | Winship Cancer Institute Atlanta, Georgia 30308, 3276 Buford Drive, Suite 200 In 2018, Winship formally launched the Center for Cancer Immunology. Atlanta, Georgia 30308, 3276 Buford Drive, Suite 200 If you are a patient currently on a clinical trial or a newly diagnosed patient considering a trial, you may be wondering how or if your clinical trial treatment could be affected by the coronavirus (COVID-19) pandemic. The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy. Shared Resources at Winship | Winship Cancer Institute Ms. Lesinski joined the CTO with over 16 years of experience in clinical trials research. Winship contributes to FDA approval of first-of-its-kind PET imaging For some patients, starting or continuing their clinical trials - even during the pandemic - is essential to their care and vital to achieving the best outcomes. Alliance A022104/NRG-GI010: A randomized phase II trial testing the Clifton Campus1365-C Clifton Road NE You can rest a little easier knowing Winship at Emory cancer center research is improving cancer treatments here in our community and globally - we are here to take care of you. We understand that this is a very stressful time. Their award-winning team has been recognized for their demonstrated leadership in, and exceptional contributions to, the development of recently FDA-approved drugs to treat multiple myeloma. PDF WIN 7493 Clinical Trials FAQ[1] In cancer clinical trials if you do not receive the new treatment being tested, you will receive the best standard treatment. R. Donald Harvey, PharmD, director of Winship's Phase I Clinical Trials Unit, has been appointed as Medical Director of the Clinical Trials Office (CTO) of Winship Cancer Institute of Emory University (Winship).. Department of Hematology and Medical Oncology, Emory Center for Experiential Learning (ExCEL), EmoryDOCS (Career Advising for Medical Students), Medical Scientist Training Program (MD/PhD). Protocol Templates | Emory University | Atlanta GA Once an IRB approval has been obtained, direct communication is made with the study sponsor and the PI regarding screening and potential enrollment of patients. Atlanta, Georgia 30342, 615 Peachtree Street NE Methods: In this Alliance for Clinical Trials in Oncology randomized phase II trial (1:1), up to 312 pts with microsatellite stable LARC, clinical stage T4N0, any T, N+ or T3N0 requiring abdominoperineal resection or coloanal anastomosis and distal margin within 12 cm of anal verge will be enrolled. Atlanta, Georgia 30342, 615 Peachtree Street NE Dr. Taofeek Owonikoko Named Chief of the Division of Hematology Earlier in March, the US Food and Drug Administration enabled NCI Comprehensive Cancer Centers like Winship the flexibility to monitor clinical trial patients remotely by conducting health assessments via virtual- and tele-visits. Jonathon Cohen, MD, MS Associate Professor, Hematology & Medical Oncology. Johns Creek, Georgia 30097, 5665 Peachtree Dunwoody Road, NE Atlanta, Georgia 30322, 36 Linden Avenue NE Brief Summary: This phase II trial studies the effects of iberdomide when given alone or in combination with dexamethasone in treating intermediate or high-risk smoldering multiple myeloma patients. It is important patients feel free to ask questions about the trials being proposed, and that these questions are fully answered before patients sign consent forms or begin therapy. The safe and effective conduct of clinical research is one of the most fundamental goals for every faculty member within our department. At present, only one caregiver may accompany you to your treatment. Bone Marrow and Stem Cell Transplantation: This treatment consists of destroying cancerous bone marrow cells by using higher doses of chemotherapy and in some cases, radiotherapy, and then replacing them with healthy bone marrow or stem cells to help patients regain a new and healthy immune system. In 2022, we enrolled more than 700 patients in over 300 interventional and treatment clinical trials. New treatments in cancer clinical trials are not always better than standard care. Your care team will include doctors, nurses, nutritionists, wellness professionals, social workers and other specialists. Winship at Emory comprehensive cancer center is proud to be innovators and leaders in national and international clinical trials in cancer. Buford, Georgia 30519, 2675 North Decatur Road Resources, Terms of Clinical Trials Monitor - Winship Clinical Trials Cancer immunology, precision medicine, and phase 1 clinical trials are areas of expertise. Cancer Patients on Clinical Trials and COVID-19 | Winship Cancer Institute There are three different groups of clinical trials which are described in phases of development. A phase II clinical trial can vary in size from 15 to 100 patients depending on how they are being evaluated. Decatur, Georgia 30033, 2801 Dekalb Medical Parkway A Phase I trial is mainly a drug safety study and tends to be small, enrolling around 20 patients. Find a Clinical Trial - Emory University Home | Winship Cancer Institute We'll help answer any questions you may have. After a drug (or procedure) is found to be effective in treating cancer in a Phase II trial, a Phase III trial will study it further. As Medical Director, Harvey will ensure the quality and compliance of clinical research practices at all Winship locations, including the Clifton campus, Emory Midtown, Emory Saint Joseph's, Emory Johns Creek, Emory Decatur, Emory Hillandale, Emory Proton Center, the VA, Grady, and Children's Healthcare of Atlanta. Phase III trials are large, enrolling hundreds or sometimes even thousands of participants. These trials give you access to some of the most advanced cancer treatments offered anywhere. Associate Director for Clinical Research, Bassel El-Rayes, MD, says this newly created position is in response to tremendous growth in the breadth of Winship's clinical trials program . (404) 778-0210. VITRAC Therapeutics to Present Phase 1 Clinical Trial Design Buford, Georgia 30519, 2675 North Decatur Road We give patients improved access to clinical trials and resources that may not be available elsewhere. Coordinated scheduling for appointments among various specialties. A completed clinical trial at Emory's Winship Cancer Institute aimed to improve the effectiveness of chemoradiation therapy in brain cancer patients by adding a new class of drug to the current standard of care while obtaining a new form of advanced MRI called spectroscopic MR imaging that may help predict who will respond to this . In 2022, we enrolled more than 700 patients in over 300 interventional and treatment clinical trials. Evaluation of bleeding risk between apixaban and rivaroxaban in The trial will proceed to the phase III portion if either of the two endpoints in the phase II cohorts is statistically superior in patients receiving encorafenib plus cetuximab. logo are trademarks of SparkCures, LLC and may not be used without permission. Winship Cancer Institute at Emory University in Atlanta, Georgia is a cancer research center that provides cancer diagnosis, treatment and support for cancer patients in Georgia. New Winship Phase I Clinical Trials Unit Opens - Emory University Nurses at Emory University Hospital, Emory Saint Joseph's Hospital, Emory Johns Creek Hospital and The Emory Clinic have earned the prestigious Magnet recognition for nursing excellence,teamwork and quality in patient care. Atlanta, Georgia 30308, 6335 Hospital Parkway Cancer patients who enroll in clinical trials gain access to innovative treatment that may not be available anywhere else. Health insurance and managed care providers do not always cover all patient care costs in a clinical trial. In these trials, people are randomized to get either the new treatment or the standard treatment. We are here to help with all aspects of cancer care physical, emotional and spiritual. Your treatment options will be tailored to your diagnosis based on the stage of your multiple myeloma and other factors such as lifestyle, age, and general health. The phase III study sample size will provide 80% power at a one-sided of 0.05 to detect an approximately 10% improvement in the three-year DFS rate, assuming 68% in . Coordinating investigator for the SPOTLIGHT study was Winship researcher David M. Schuster, MD, FACR, professor of radiology and imaging sciences at Emory University School of Medicine. We offer a comprehensive approach to breast health and breast cancer treatment, combining the latest technology and research in a compassionate and caring environment. If clinical trials managed by Winship CTO, please refer to Winship Clinical Trials Procedure for External Sponsor Monitors Conducting Remote Monitoring Visits The PI, research nurse, CRC, or access coordinator1 will: Complete the EHC Access Request Form (including monitor's last 4 digits of SSN & full DOB) R. Donald Harvey, PharmD, director of Winship's Phase I Clinical Trials Unit, has been appointed as Medical Director of the Clinical Trials Office (CTO) of Winship Cancer Institute of Emory University (Winship). If you have been diagnosed with multiple myeloma, they are ready to help you. Suresh S. Ramalingam, MD., FASCO , Executive Director. The Protocol Review and Monitoring Committee (PRMC) provides scientific review of all oncology related protocols, in preparation for review by the Emory University Institutional Review Board. If you or someone you love needs cancer treatment, you want expert care, right away. Phase I at Winship In 2013, 760 patients were enrolled in 250 Winship clinical trials, testing new therapies. In 2014, Winship was selected as one of NCIs Lead Academic Participating Sites to provide leadership to the National Clinical Trials Network. "In the last two years, Winship has activated more clinical trials and enrolled more patients than ever. The basis of all clinical trials is the delivery of the highest level of clinical care, and through clinical trials, patients have access to the latest and most innovative treatment options. Winship has tripled the size of its dedicated Phase I Clinical Trials Unit, the largest facility of its kind in Georgia. A relationship is now established between the patient and the research nurse once the Informed Consent has been obtained and screening appointments are scheduled such as CT exams, laboratory, etc. For more information, contact our Clinical Trials Office at (404) 778-1868. Winship Cancer Institute of Emory University Myeloma Trials - SparkCures VITRAC Therapeutics, LLC (VITRAC) presented a poster on the Phase 1a/1b clinical trial of aurora kinase A (AURKA) inhibitor, VIC-1911, as monotherapy and in combination with KRAS G12C inhibitor, sotorasib. Phase I trials: Where all anticancer drugs begin - Emory University Reports of all monitoring activities are reviewed by the DSMC. Buford, Georgia 30519, 2675 North Decatur Road As Georgia's NCI Comprehensive Cancer Center, we are at the forefront of cancer research, innovation, and discovery. Copyright Emory Healthcare 2022 - All Rights Reserved | Download Adobe Reader. Winship Cancer Institute is part of Emory Healthcare, Georgia's largest health care system. Atlanta, Georgia 30308, 3276 Buford Drive, Suite 200 View our calendar of community events, patient activities, and professional continuing education events. For reliable, in-depth information about cancer symptoms, staging and diagnosis, visit CancerQuest, an educational and outreach program at Emory University. Winship Clinical Trials . This is done to avoid any type of bias in interpreting the results. Title RSPH5056-20: Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer Summary Primary Objective: Decatur, Georgia 30033, 2801 Dekalb Medical Parkway Clifton Campus1365-C Clifton Road NE Clinical Trials at Winship At Winship, our patients have access to clinical trials for virtually every cancer type. This Web site is provided solely for personal and private use of individuals accessing this information, and no part of it may be used for any other purpose. This includes imaging techniques, chemotherapy and radiation treatments, and more. The treatment may be given to people with different types of cancers. For other patients, starting a clinical trial or continuing a trial can be safely delayed or paused without significantly impacting the progression of their cancer and/or changing their outcomes. Such virtual visits give patients and their care teams access to each other and the data they need, but without requiring the cancer patient to come to the cancer center. Cancer clinical trials offer high-quality cancer care. R. Donald Harvey, Pharm D, director of Winship's Phase I Clinical Trials Section, has been appointed as Medical Director of the Clinical Trials Office of Winship Cancer Institute of Emory University. We care for the whole person body, mind and spirit. Phase II trials study how well a treatment works for a certain cancer. Our investigators conduct a broad range of studies, including a large number of clinical trials that evaluate new drugs or agents, new devices, new regimens, and/or new strategies for the treatment and prevention of cancer. Jacquis Presley Clin Research Coord, Qual Mgmt. Through clinical trials, Winship specialists pioneer the world's most promising treatments of tomorrow. Winship members research productivity is demonstrated in many high-impact papers published every year. The protocol, or in some cases a detailed protocol proposal, is reviewed by the therapeutic area Working Group. To ensure patient safety and to achieve the best outcomes, cancer patients on clinical trials are monitored more frequently than patients on standard therapies, and increased monitoring has traditionally occurred face-to-face with the care team in a cancer center. Lithonia, Georgia 30058, Winship Cancer Institute of Emory University, Winship Cancer Institute of Emory University, Winship Cancer Institute at Emory Midtown, approve pending revisions with administrative approval possible, approve pending revisions to be reviewed by the specified committee members. Atlanta, Georgia 30322, 36 Linden Avenue NE Sometimes a drug is being used for the first time in humans. Participating in a clinical trial enables patients to receive the latest and potentially most effective treatment for their cancer. BOSTON--(BUSINESS WIRE)-- VITRAC Therapeutics, LLC (VITRAC) presented a poster on the Phase 1a/1b clinical trial of aurora kinase A (AURKA) inhibitor, VIC-1911, as monotherapy and in combination with KRAS G12C inhibitor, sotorasib.The study targets the treatment of KRAS G12C-mutant non-small cell lung cancer (NSCLC).The findings were presented at the prestigious 2023 American Society of . Winship has pioneered many advances in bone marrow transplant procedures and drugs. Conversely, the Winship myeloma trials, conducted between 2014 and 2021, included 34% Black patients. The initial study section in the eIRB must be completed in order to generate and IRB number. at the National Institutes of Health, An official website of the United States government, Frederick National Laboratory for Cancer Research, U.S. Department of Health and Human Services. Studies taking place at the Winship Cancer Institute should use the Winship Clinical Protocol Template. Your care team at Winship is uniquely qualified to help you make treatment decisions that deliver the best outcomes, and in certain situations, those best outcomes are achieved through a clinical trial. "The highly variable nature of recurrent prostate cancer presents clinical challenges, and up to 40% of patients who undergo radical prostatectomy, and up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years," says Schuster. In the past ten years, their multiple myeloma experts have helped pioneer new drug therapies that have doubled the life expectancy of patients, and they are dedicated to building on that success. An innovative study led by Winship investigators has uncovered a simplified, economical manufacturing process for generating more potent and metabolically fit human T-cell therapies to treat solid tumors. U.S. News & World Report ranks Emory University among the Best Global Universities for Oncology. VITRAC Therapeutics is a comprehensive oncology research and development company, excelling in the development, management, and optimization of global pharmaceutical drug development programs . Your clinical care team at Winship can tell you about the known benefits and potential risks of a clinical trial as well as other available treatment options. At Winship, access to clinical trials is available at all of our locations in the Atlanta area. Atlanta, Georgia 30308, 3276 Buford Drive, Suite 200 The Working Group evaluates the study in terms of the specific items set forth in the feasibility review and Data Safety Monitoring Plan (DSMP) assigning a priority protocol assessment score. Our physicians and surgeons are responsible for some of the most significant innovations and treatments in the country. Patients with cancer are at higher risk of complications from COVID-19. Treatments, About Decatur, Georgia 30033, 2801 Dekalb Medical Parkway The study suggests that using fewer of the activation beads could be cost saving if adapted for future clinical trials. INDAPTUS THERAPEUTICS ACTIVATES EMORY WINSHIP CANCER INSTITUTE AS TRIAL SITE IN INDP-D101, ITS ONGOING PHASE 1 OPEN LABEL CLINICAL TRIAL OF DECOY20 IN PATIENTS WITH ADVANCED SOLID TUMORS. At Winship Cancer Institute, DOACs are used for the treatment of cancer-associated VTE for patients with GI malignancies. VITRAC Therapeutics to Present Phase 1 Clinical Trial If the Working Group approves the study, the Working Group Chair signs the PRMC submission form which has been completed by the Principal Investigator (PI). "The new Phase I Clinical Trials Unit is a tremendous resource that will enable the very best research in the clinical setting." * This profile was provided by the Winship Cancer Institute. Winship offers you a comprehensive treatment plan customized for your disease by giving you access to genetic testing, molecular sequencing and expert assessment. The review and approval process begins with a clinical investigator/faculty member who proposes the study concept. Critical Updates in Clinical Research - Emory University Their award-winning team has been recognized for their demonstrated leadership in, and . Here are several precautions to consider when receiving treatment: Drug-related fever usually happens around the time of infusion and is not associated with typical symptoms of COVID-19 (cough, shortness of breath, sore throat, etc.) Emory doctors do more than practice medicine they advance it. These reviews are in addition to the reporting requirements established by the IRB, which may include semi-annual as well as annual reports. Clifton Campus1365-C Clifton Road NE We give patients improved access to clinical trials and resources that may not be available elsewhere. A randomized trial of consolidation-targeted adjuvant therapy with Winship physicians provide cancer care at the following locations: Emory University Hospital, Emory University Hospital Midtown, Emory Saint Josephs Hospital, Emory Johns Creek Hospital, Emory Proton Therapy Center, Grady Memorial Hospital, and the Atlanta VA Medical Center. The IRB reviews the protocol and if questions are raised or revisions are required, the CTO or the individual department's regulatory staff assists the PI in responding to the IRB. Chief, Division of Surgical Oncology, Winship Cancer Institute of Emory University. Our supportive oncology team addresses these issues in a timely manner with additional support from counselors, nurse navigators, dietitians and social service professionals. In addition to delivering the highest quality medical care, we recognize the importance of the psychological and emotional aspects of living with a cancer diagnosis and of dealing with treatment. At 17 years old, Terna Ityokumbul was like most high school students: consumed with friends, graduation and the future. Winship not only kept patients on track who were already participating in clinical trials, but also managed to open new clinical trials during the pandemic and enroll many new patients. Associate Director for Clinical Research, Bassel El-Rayes, MD, says this newly created position is in response to tremendous growth in the breadth of Winship's clinical trials program, and this role is critical to advance the successful execution of Winship's clinical research efforts. These trials may include between 25 and 100 people. Winship has tripled the size of its dedicated Phase I Clinical Trials Unit, the largest facility of its kind in Georgia. A leading expert in the care of colorectal cancer and other gastrointestinal malignancies, Dr. Staley leads the surgical oncology team at Winship. See if you qualify! Lithonia, Georgia 30058, Winship Cancer Institute of Emory University, Winship Cancer Institute of Emory University, Winship Cancer Institute at Emory Midtown. If a new patient is identified as appropriate for the study, the PI overviews the study with the patient and notifies the research nurse. Winship's shared resources are supported by the Cancer Center Support Grant from the National Cancer Institute. The research nurse then reviews all the screening records necessary for inclusion into the clinical trials with the PI for approval. Use the filters below to find active studies currently open for enrollment. At Winship Cancer Institute, phase I clinical trials are conducted within the Phase I Unit located in the Emory University Hospital Tower. The following is a listing of clinical trials for patients with multiple myeloma who have been newly diagnosed or have not yet received treatment. Phase III trials may look at different doses of the same drug, different drug combinations or different sequences of giving drugs. Winship researcher David M. Schuster, MD, was the coordinating investigator for a phase 3 clinical trial of POSLUMA, the first radiohybrid drug for PET imaging of prostate-specific membrane antigen-positive lesions in men with prostate cancer. Providing hope for patients with cancer. Phase II clinical trials are designed to test the actual effectiveness of a given treatment once the dose has been established. In the last seven years, 75-percent of new cancer treatments approved by the Food and Drug Administration have been tested in clinical trials available at Winship. Please highlight the cancer relevance of your research, if it is not obvious. The findings were presented at the prestigious 2023 . If you or a loved one needs cancer treatment or would like a second opinion, we can help. From mid-March until the end of August, 78 new clinical trials opened at Winship and 329 patients enrolled on interventional trials. Deeper mechanistic investigations used cutting-edge assays (lab tests to measure amounts of specific substances) to reveal that not only were the resulting cells less differentiated, but they possessed an optimal metabolic profile, making them more bioenergetically fit. Winship Cancer Institute NCT ID Protocol Number STUDY00000563 Contact If interested in learning more about this clinical trial, please contact winshipcto@emory.edu or (404) 778-1868. If you have a fever, cough or shortness of breath, contact your care team before you come to a Winship facility for your clinical trial treatment. Atlanta, Georgia 30308, 6335 Hospital Parkway Terna was an athlete all his life, and from a young age, he had a dream to play college football. Precision PET imaging with POSLUMA can identify primary and metastatic prostate cancer, providing valuable information to help doctors and patients determine a course of treatment.The FDA approval was based on data from two phase 3 trials (LIGHTHOUSE and SPOTLIGHT), which established the safety and diagnostic performance of POSLUMA in 747 patients with initial or recurrent prostate cancer. Atlanta, Georgia 30342, 615 Peachtree Street NE Decatur, Georgia 30033, 2801 Dekalb Medical Parkway Buford, Georgia 30519, 2675 North Decatur Road Winship Clinical Trials. The following is a list of myeloma clinical trials at this center.
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