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: 8231496
• 负责人: PAMELA U FREDA
• 金额: $ 34.51万
• 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/8231496
• 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.

项目概要 该项目将开展首个临床非临床综合前瞻性研究 功能性垂体腺瘤（CNFA）。当前评估、治疗的临床实践 对这些垂体腺瘤患者的随访是基于回顾性收集的 数据，有很多缺点。因此，我们对以下方面的认识存在重大差距： 如何优化这些实践。改善我们治疗这些患者的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它。我们将克服这个 障碍并回答有关 CNFA 护理的重要悬而未决的问题。本项目的目标1 是前瞻性研究不需要手术干预的无症状垂体病变 以确定适当的初步评估和后续行动以及其安全性 保守的、非手术的治疗。该项目的目标 2 是前瞻性评估 有症状的 CNFA 的结果是手术治疗，初始治疗的选择。 手术后复发很常见，但无法可靠预测，因此我们将研究 肿瘤再生长的潜在危险因素，特别是“沉默”促肾上腺皮质激素肿瘤类型。我们将 还评估了术后有小肿瘤残留的患者保守随访的安全性 手术并通过检查风险与治疗结果来确定哪些患者需要放疗。 术后放疗对残留/复发肿瘤的好处。该项目的目标 3 是检查 首次前瞻性地了解该疾病和我们的疗法对生活质量和 CNFA 患者的神经认知功能。该项目的目标 4 是建立一个新颖的 我们队列中的垂体瘤标本库将与广泛的临床研究相关 我们的前瞻性研究中收集的数据。该银行将成为未来的宝贵资源 肿瘤标志物的协作研究及其临床意义。 我们的研究团队拥有内分泌学、神经外科、认知学方面的专业知识 神经科学和病理学完全有资格并有能力开展这项研究。大的 转介到该团队的患者数量使我们能够很好地开展这项研究。项目 通过建立一个庞大且独特的前瞻性随访队列进一步加强 CNFA 患者的研究并建立了与其临床相关的垂体瘤库 数据。该项目将为评估、治疗和管理提供新的数据 患有临床无功能垂体腺瘤的患者。