CF 3: Clinical Trials & Advocacy Core

CF-3：临床试验和宣传核心 摘要 肉瘤是一种罕见的、异质性的间叶性恶性肿瘤，可影响 各个年龄段的人。肉瘤预示着预后不良，估计三年存活率为 转移性疾病患者为20%。肉瘤患者的治疗严重滞后。 落后于那些可用于上皮和血液系统恶性肿瘤的药物。因此肉瘤代表了 这是一个潜力未被满足的领域，其中存在着对临床前和临床发展的巨大需求。 肉瘤的临床研究提出了独特的挑战，这是为罕见患者服务所固有的 每种疾病亚型具有独特的生物、致病、遗传和表观遗传学基础的群体 这可以被定性，并在治疗上加以利用。肉瘤的临床试验是一项 需要特别关注、倡议、基础设施和专业知识的劳动密集型行业， 除了任何主要的癌症中心之外。 临床试验和宣传核心(CF-3)的主要目标是支持 软组织肉瘤中MSKCC孢子的临床作用。CF-3将由KEY联合运行 纪念斯隆-凯特琳癌症中心成人和儿童肉瘤项目成员 (MSKCC)，确保在所有年龄段流畅地应用新疗法。CF-3将桥接 MSKCC的成人和儿童肉瘤计划；基础科学、翻译和临床方面 各种孢子项目；以及行政、生物统计和生物质学家核心。 此外，CF-3将促进与其他肉瘤孢子的无缝临床协作， 临床试验的合作/政府资助机制(ETCTN/癌症治疗评估 计划[CTEP]/联盟)、制药公司、倡导团体以及免疫和 发展性治疗方案。CF-3将为孢子调查人员提供专业知识 临床试验开发和管理，临床试验的支持人员，专业知识和 管理临床试验相关性，为进行临床试验和实施提供财政支持 相关研究，以及开发和获得罕见疾病新疗法的机制。这个 Cf-3，与其他孢子核心密切合作，将提供急需的基础设施，以 确保孢子的翻译使命在不同年龄段之间以及时、成本- 高效、合作的态度。 Cf-3将致力于促进少数族裔参与者参与我们的 临床研究。Cf-3还将制定一项计划，让患者倡导和支持团体参与其中， 开发我们的临床试验方案的目标是最好地服务于患者的需求。这一目标将 也有一个教育部分，将允许MSKCC肉瘤之间的对话 疾病管理团队和患者、护理者和倡导者。

CF-3: Clinical Trials and Advocacy Core ABSTRACT Sarcomas are a rare and heterogeneous group of malignancies of mesenchymal origin that affect individuals of all ages. Sarcomas portend a poor prognosis with an estimated three-year survival rate of 20% for patients with metastatic disease. Treatments for patients with sarcoma have greatly lagged behind those available for the epithelial and hematopoietic malignancies. Sarcoma therefore represents an area of unmet potential in which there is a tremendous need for preclinical and clinical advancement. Clinical research on sarcoma presents unique challenges that are inherent to serving a rare patient population with each disease subtype having a unique biologic, pathogenic, genetic, and epigenetic basis that can be characterized and therapeutically exploited. The conduct of clinical trials on sarcoma is a labor-intensive undertaking that requires specific attention, initiatives, infrastructure, and expertise, apart from and in addition to those of any major cancer center. The main objective of the Clinical Trials and Advocacy Core (CF-3) is to support the translational and clinical efforts of the MSKCC SPORE in Soft Tissue Sarcoma. The CF-3 will be jointly run by key members of the adult and pediatric sarcoma programs at Memorial Sloan Kettering Cancer Center (MSKCC), ensuring the fluid application of novel therapies across all age groups. The CF-3 will bridge the adult and pediatric sarcoma programs at MSKCC; the basic science, translational, and clinical aspects of the various SPORE projects; and the Administrative, Biostatistical, and Biospecimen Cores. Additionally, the CF-3 will facilitate seamless clinical collaboration with other Sarcoma SPOREs, cooperative/government funding mechanisms for clinical trials (ETCTN/Cancer Therapy Evaluation Program [CTEP]/Alliance), pharmaceutical companies, advocacy groups, and immune and developmental therapeutic programs. The CF-3 will provide SPORE investigators with expertise in clinical trial development and administration, support staff for the clinical trials, expertise in and administration of clinical trial correlates, financial support for conducting clinical trials and performing correlative studies, and mechanisms for developing and acquiring novel therapies for rare diseases. The CF-3, in close collaboration with the other SPORE cores, will provide the much-needed infrastructure to ensure that the translational mission of the SPORE is realized across age groups in a timely, cost- effective, and cooperative manner. CF-3 will work to facilitate the engagement and involvement of minority participants in our clinical research. CF-3 will also develop a program to involve patient advocacy and support groups, with the goal of developing our clinical trial protocols to best serve the needs of the patients. This aim will also have an educational component, which will allow for conversations between the MSKCC Sarcoma Disease Management Team and patients, caregivers, and advocates.