CF 3: Clinical Trials & Advocacy Core

CF 3：临床试验

• 批准号: 10468961
• 负责人: William D. Tap
• 金额: $ 6.49万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10468961
• 关键词: Address; Adult; Advocacy; Advocate; Affect; Age; Area; Attention; Awareness; Basic Science; Biological; Biological Markers; Biology; Biometry; Cancer Center; Cancer Therapy Evaluation Program; Caregivers; Caring; Childhood; Clinical; Clinical Cancer Center; Clinical Research; Clinical Trials; Clinical Trials Unit; Clinical trial protocol document; Collaborations; Communities; Complement; Conduct Clinical Trials; Correlative Study; Data Analyses; Data Collection; Development; Developmental Therapeutics Program; Disease; Disease Management; Education; Ensure; Epigenetic Process; Epithelial; Financial Support; Funding Mechanisms; Genetic; Goals; Government; Hematopoietic Neoplasms; Immunotherapeutic agent; Individual; Infrastructure; Liquid substance; Logistics; Malignant Neoplasms; Medical; Memorial Sloan-Kettering Cancer Center; Mesenchymal; Minority; Oncologist; Oncology; Participant; Pathogenicity; Patient Recruitments; Patient advocacy; Patients; Performance; Pharmacologic Substance; Population; Process; Prognosis; Protocols documentation; Rare Diseases; Research; Research Personnel; Research Project Grants; Resources; Running; Site; Soft tissue sarcoma; Structure; Support Groups; Survival Rate; Therapeutic; Time; Translational Research; Translations; Underrepresented Populations; Underserved Population; United States National Institutes of Health; Work; age group; childhood sarcoma; cost effective; design; disorder subtype; effective therapy; experimental study; improved; member; novel; novel therapeutics; outreach; patient advocacy group; patient population; pre-clinical; prevent; programs; sample collection; sarcoma; translational goal

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.

CF-3：临床试验和宣传核心 抽象的 肉瘤是一组罕见且异质的间质来源的恶性肿瘤，影响 所有年龄段的个人。肉瘤预示着预后不良，估计三年生存率为 患有转移性疾病的患者为 20%。肉瘤患者的治疗大大滞后 落后于那些可用于上皮和造血系统恶性肿瘤的药物。因此肉瘤代表 这是一个潜力未得到满足的领域，非常需要临床前和临床进展。 肉瘤的临床研究提出了服务罕见患者所固有的独特挑战 每种疾病亚型都有独特的生物学、致病性、遗传和表观遗传基础的人群 可以对其进行表征并进行治疗利用。肉瘤临床试验的进行是 需要特别关注、举措、基础设施和专业知识的劳动密集型事业， 除了任何主要癌症中心之外。 临床试验和倡导核心 (CF-3) 的主要目标是支持转化 以及 MSKCC SPORE 在软组织肉瘤方面的临床工作。 CF-3将由关键人员共同运营 纪念斯隆凯特琳癌症中心成人和儿童肉瘤项目的成员 (MSKCC)，确保新疗法在所有年龄段的流畅应用。 CF-3将桥接 MSKCC 的成人和儿童肉瘤项目；基础科学、转化和临床方面 各种 SPORE 项目；以及行政、生物统计和生物样本核心。 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 发育治疗计划。 CF-3 将为 SPORE 调查员提供以下方面的专业知识 临床试验开发和管理、临床试验支持人员、专业知识和 临床试验相关管理、进行临床试验和执行的财务支持 相关研究以及开发和获取罕见疾病新疗法的机制。这 CF-3 与其他 SPORE 核心密切合作，将提供急需的基础设施 确保 SPORE 的转化使命在各个年龄段及时、成本低廉地实现 有效、合作的方式。 CF-3 将努力促进少数群体参与者参与我们的活动 临床研究。 CF-3 还将制定一项让患者倡导和支持团体参与的计划， 制定临床试验方案以最好地满足患者需求的目标。这一目标将 还有一个教育部分，允许 MSKCC 肉瘤之间进行对话 疾病管理团队以及患者、护理人员和倡导者。