Evaluation of the Natural History of Patients withTumors of the Central Nervous

中枢神经肿瘤患者自然史的评估

• 批准号: 8763556
• 负责人: Teri Kreisl
• 金额: $ 22.68万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8763556
• 关键词: Accounting; Adjuvant Chemotherapy; Age-Months; American Cancer Society; Anesthesia procedures; Blood - brain barrier anatomy; Brain; Brain Neoplasms; Cancer Patient; Caring; Central Nervous System Neoplasms; Characteristics; Child; Clinical; Clinical Trials; Consent Forms; Cytotoxic agent; Data; Disease; Drug Delivery Systems; Eligibility Determination; Evaluation; Excision; Future; Glioma; Growth; Hypoxia; Image; Infiltrative Growth; Informed Consent; Legal Guardians; Light; Malignant Glioma; Malignant Neoplasms; Medical; Medical Students; Modality; Natural History; Nervous System Neoplasms; Nervous System Trauma; Neuraxis; New Agents; Nurses; Operative Surgical Procedures; Outcome; Parents; Pathology; Patients; Phase; Physicians; Protocols documentation; Radiation therapy; Recording of previous events; Recurrence; Recurrent disease; Resistance; Secondary to; Subgroup; Survival Rate; Techniques; Time; United States National Institutes of Health; Writing; cellular targeting; chemotherapy; design; effective therapy; interest; member; neuro-oncology; neuroimaging; novel; outcome forecast; temozolomide; tumor; tumor progression; willingness

Background: This protocol is designed to evaluate patients with tumors of the central nervous system (CNS) who appear to be probable candidates for future protocol entry or have disease manifestations that are of unique scientific interest, importance, and/or educational value. Objectives: 1) To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols. 2) To follow patients with tumors of the CNS that are representative of important scientific and/or clinical principles. 3) To allow a steady flow of patients with tumors of the CNS at the NIH for the purpose of educating nurses, medical students, residents, clinical fellows, and physicians in the management and care of this specialized subgroup of cancer patients. Eligibility: 1) All patients 12 months of age with tumors of the CNS of interest to the NOB, who may be candidates for another NOB trial at some point in the future. 2) Patients with tumors of the CNS that are of particular interest to members of the NOB because they pose important clinical and/or scientific questions and/or shed light on important aspects of the disease. 3) Patients with tumors of the CNS who offer an important educational benefit to neuro-oncology trainees and staff. 4) Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. Availability of a parent or legal guardian to give informed consent for children. Design: 1) All patients will undergo an initial evaluation at the Clinical Center by a member of the NOB where past medical and oncologic histories will be obtained as well as relevant data such as neuroimaging and pathology review. A total of 3,000 patients will be accrued to this study. 2) Patients may be seen at the NIH Clinical Center at varying intervals depending on the clinical situation but data related to the natural history of their disease course and outcome will be collected at least every six months.

背景：该方案旨在评估中枢神经系统肿瘤（CNS）的患者，这些患者似乎是未来方案进入的候选者或具有独特的科学兴趣，重要性和/或教育价值的疾病表现。目标：1）评估中枢神经系统肿瘤（CNS）的患者，这些患者可能是NCI I期和II阶段方案的未来候选者。 2）跟随代表重要科学和/或临床原理的中枢神经系统肿瘤的患者。 3）允许NIH中枢神经系统肿瘤的患者稳定流动，以便对护士，医学生，居民，临床研究员和医生进行教育和护理癌症患者的专业亚组。资格：1）所有患者患有感兴趣的中枢神经系统肿瘤的12个月大患者，他们将来可能是另一项NOB试验的候选人。 2）中枢神经系统肿瘤的患者特别感兴趣的是NOB成员，因为它们在疾病的重要方面提出了重要的临床和/或科学问题和/或阐明。 3）中枢神经系统肿瘤的患者为神经肿瘤学员和员工提供重要的教育益处。 4）受试者或合法授权代表（LAR）理解和愿意签署书面知情同意文件的能力。父母或法定监护人的可用性以给予儿童知情同意。设计：1）所有患者将在临床中心接受初步评估，而NOB将获得过去的医学和肿瘤学历史以及相关数据，例如神经影像学和病理学综述。这项研究总共将累积3,000名患者。 2）根据临床情况，可以在NIH临床中心看到患者，但至少每六个月至少每六个月收集与其疾病病史和结果有关的数据。