Prospective Study of Clinically Non-functioning Pituitary Adenomas

临床无功能垂体腺瘤的前瞻性研究

• 批准号: 8500481
• 负责人: PAMELA U FREDA
• 金额: $ 33.31万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-01 至 2015-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8500481
• 关键词: Caring; Clinical; Clinical Data; Corticotropin; Data; Development; Disease; Endocrine; Endocrinology; Evaluation; Functional disorder; Future; Growth; Guidelines; Investigation; Knowledge; Lead; Lesion; Link; Molecular; Monitor; Neurocognitive; Neurologic Dysfunctions; Operative Surgical Procedures; Outcome; Outcome Study; Pathology; Patient Care; Patients; Pituitary Gland; Pituitary Gland Adenoma; Pituitary Neoplasms; Plasma; Prevalence; Prospective Studies; Qualifying; Quality of life; Recurrence; Recurrent tumor; Reporting; Research Personnel; Residual state; Resources; Risk; Risk Factors; Safety; Series; Specimen; Therapy Evaluation; Time; Tumor Bank; Tumor Markers; base; clinical care; clinical practice; clinically significant; cognitive neuroscience; cohort; follow-up; improved; molecular marker; neurosurgery; novel; prospective; tumor; tumor growth

PROJECT SUMMARY This project will conduct the first comprehensive prospective study of clinically non- functioning pituitary adenomas (CNFA). Current clinical practices for the evaluation, treatment and follow up of patients with these pituitary adenomas are based on retrospectively collected data, which have many shortcomings. As a result, significant gaps exist in our knowledge about how to optimize these practices. A major barrier to improving our approach to these patients has been the lack of prospectively collected evidence to support or change it. We will overcome this barrier and answer the important outstanding questions about CNFA care. Aim 1 of this project is to prospectively study asymptomatic pituitary lesions that do not require surgical intervention in order to determine the appropriate initial evaluation and follow up as well as the safety of their conservative, non-surgical management. Aim 2 of this project is to prospectively assess the outcome of symptomatic CNFAs treated with surgery, the initial treatment of choice. Recurrences after surgery are common, but cannot be reliably predicted so we will study potential risk factors for tumor re-growth in particular the "silent" corticotroph tumor type. We will also assess the safety of conservative follow up for patients with small tumor remnants after surgery and determine in which of these patients RT is needed by examining the risks vs. benefits of post-operatively RT for residual/recurrent tumors. Aim 3 of the project is to examine for the first time, prospectively, the impact of the disease and our therapies on quality of life and neurocognitive function in patients with CNFAs. Aim 4 of the project will be to establish a novel bank of pituitary tumor specimens from our cohort that will be linked to the extensive clinical data collected in our prospective study. This bank will serve as a valuable resource for future collaborative studies of tumor markers and their clinical significance. Our investigative team with expertise in Endocrinology, Neurosurgery, Cognitive Neuroscience and Pathology is well qualified and equipped to undertake this study. The large number of patients referred to the team make us well situated to conduct this study. The project is further strengthened by its establishment of a large and unique prospectively followed cohort of CNFA patients and by its creation of a bank of pituitary tumors that is linked to its clinical data. This project will provide novel data on the evaluation, treatment and management of patients with clinically non-functioning pituitary adenomas.

项目总结 该项目将进行第一个全面的前瞻性研究的临床非 功能性垂体腺瘤(CNFA)。目前的临床做法是对其进行评估、治疗 对这些垂体腺瘤患者的随访是基于回顾收集的 数据，它有很多缺点。因此，我们对以下问题的认识存在重大差距 如何优化这些实践。改进我们对这些患者的治疗方法的一个主要障碍是 缺乏前瞻性收集的证据来支持或改变这一点。我们会克服这一点的 屏障并回答CNFA护理的重要悬而未决的问题。本项目的目标1 是前瞻性地研究不需要手术干预的无症状的脑下垂体病变 为了确定适当的初步评估和后续行动以及其安全性 保守的非手术治疗。该项目的目标2是前瞻性地评估 对症状性CNFAs的治疗结果，首选手术治疗。 手术后复发很常见，但不能可靠地预测，所以我们将研究 肿瘤再生长的潜在危险因素，特别是“无症状的”促肾上腺皮质细胞肿瘤类型。我们会 同时评估术后小肿瘤残留患者保守随访的安全性。 手术并通过检查风险与 术后放疗对残留/复发肿瘤的益处。该项目的目标3是检查 第一次，前瞻性地，疾病和我们的治疗对生活质量和 CNFAs患者的神经认知功能。该项目的目标4将是建立一部小说 我们队列中的一批垂体瘤标本将与广泛的临床研究相关联 在我们的前瞻性研究中收集的数据。这家银行将成为未来的宝贵资源。 肿瘤标志物的合作研究及其临床意义。 我们的调查团队在内分泌学、神经外科、认知学方面拥有专业知识 神经科学和病理学非常有资格和装备来进行这项研究。大的 转诊给团队的患者数量使我们处于进行这项研究的有利位置。该项目 通过建立一个庞大而独特的前瞻性跟踪队列，进一步加强了 通过建立一个与其临床相关的脑垂体瘤库 数据。该项目将提供有关评估、治疗和管理的新数据。 临床上无功能的垂体腺瘤患者。