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: 7861520
• 负责人: PAMELA U FREDA
• 金额: $ 35.17万
• 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/7861520
• 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; Surgical Management; 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; public health relevance; tumor; tumor growth

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: In this project we will conduct a unique prospective study of a large cohort of patients with clinically non-functioning pituitary tumors. We will investigate important unanswered questions about the evaluation, management and treatment of patients with these tumors. We will investigate the safety of conservative nonsurgical management of patients with asymptomatic pituitary lesions. We will also investigate the most appropriate follow up of patients who have undergone surgery as well as identify patients who are at greatest risk for tumor regrowth after surgery. We will also establish a bank of pituitary tumors from this cohort that can serve as a novel resource for future investigations into the molecular mechanisms of pituitary tumor growth. Our study will lead to important new knowledge about the care of patients with clinically nonfunctioning pituitary tumors.

描述（由申请人提供）：本项目将进行临床无功能垂体腺瘤（CNFA）的首次全面前瞻性研究。目前临床实践的评估，治疗和随访这些垂体腺瘤患者的基础上回顾性收集的数据，有许多缺点。因此，我们在如何优化这些实践方面的知识存在重大差距。改善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它。我们将克服这一障碍，并回答有关CNFA治疗的重要悬而未决的问题。本项目的目的1是前瞻性研究不需要手术干预的无症状垂体病变，以确定适当的初始评估和随访以及保守非手术治疗的安全性。该项目的目的2是前瞻性评估手术治疗症状性CNFA的结果，手术是最初的治疗选择。手术后复发是常见的，但不能可靠地预测，所以我们将研究肿瘤再生长的潜在风险因素，特别是“沉默”促肾上腺皮质激素细胞肿瘤类型。我们还将评估术后小肿瘤残留患者保守随访的安全性，并通过检查术后残留/复发肿瘤RT的风险与受益来确定哪些患者需要RT。该项目的目的3是首次前瞻性地检查疾病和我们的治疗对CNFA患者生活质量和神经认知功能的影响。该项目的目标4将是建立一个新的垂体瘤标本库，该标本库将与我们前瞻性研究中收集的广泛临床数据相关联。该库将为今后肿瘤标志物及其临床意义的合作研究提供宝贵的资源。 我们的研究团队拥有内分泌学、神经外科学、认知神经科学和病理学方面的专业知识，具备开展这项研究的资格和条件。大量的患者被转介到该团队，使我们能够很好地进行这项研究。该项目通过建立一个庞大而独特的前瞻性随访CNFA患者队列以及建立一个与其临床数据相关的垂体瘤库而得到进一步加强。该项目将提供关于临床无功能垂体腺瘤患者的评估、治疗和管理的新数据。 公共卫生相关性：在这个项目中，我们将进行一个独特的前瞻性研究，一个大型队列的患者临床无功能垂体瘤。我们将调查有关这些肿瘤患者的评估，管理和治疗的重要未回答的问题。我们将探讨无症状垂体病变患者保守非手术治疗的安全性。我们还将研究对接受手术的患者进行最适当的随访，并确定手术后肿瘤再生长风险最大的患者。我们还将建立一个垂体肿瘤库，为今后研究垂体肿瘤生长的分子机制提供新的资源。我们的研究将为临床无功能垂体瘤患者的护理提供重要的新知识。