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: 8629798
• 负责人: PAMELA U FREDA
• 金额: $ 34.17万
• 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 2017-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8629798
• 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.

项目摘要 该项目将进行第一次全面的前瞻性研究， 功能性垂体腺瘤（CNFA）。目前的临床实践的评价，治疗 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，我们在以下方面的知识存在重大差距： 如何优化这些实践。改善我们对这些患者的治疗方法的主要障碍是 缺乏前瞻性收集的证据来支持或改变它。我们将克服这一点 障碍，并回答有关CNFA护理的重要悬而未决的问题。项目目标1 是前瞻性研究不需要手术干预的无症状垂体病变 为了确定适当的初始评价和随访以及其安全性， 保守的非手术治疗本项目的目标2是前瞻性地评估 手术治疗的症状性CNFA的结果，最初的治疗选择。 手术后复发很常见，但不能可靠预测，因此我们将研究 肿瘤再生长的潜在危险因素，特别是“沉默的”促肾上腺皮质激素细胞肿瘤类型。我们将 还评估了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RT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的影响， CNFA患者的神经认知功能。该项目的目标4将是建立一个新的 来自我们队列的垂体瘤标本库，将与广泛的临床研究相关联。 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。 肿瘤标志物的协同研究及其临床意义。 我们的研究团队拥有内分泌学、神经外科学、认知神经科学和神经外科学的专业知识。 神经科学和病理学部具备开展本研究的资质和条件。大 转介给该小组的患者数量使我们能够很好地进行这项研究。项目 通过建立一个庞大而独特的前瞻性随访队列， CNFA患者，并建立了一个垂体瘤库，与其临床 数据该项目将提供关于评估、治疗和管理 临床上无功能的垂体腺瘤患者。

项目成果

Pituitary incidentaloma: an endocrine society clinical practice guideline.

• DOI: 10.1210/jc.2010-1048
• 发表时间: 2011-04
• 期刊: The Journal of clinical endocrinology and metabolism
• 作者: Freda PU;Beckers AM;Katznelson L;Molitch ME;Montori VM;Post KD;Vance ML;Endocrine Society
• 通讯作者: Endocrine Society

Temozolomide (Temodar®) and capecitabine (Xeloda®) treatment of an aggressive corticotroph pituitary tumor.

替莫唑胺 (Temodar®) 和卡培他滨 (Xeloda®) 治疗侵袭性促肾上腺皮质激素垂体瘤。

• DOI: 10.1007/s11102-009-0211-1
• 发表时间: 2011
• 期刊: Pituitary
• 影响因子: 3.8
• 作者: Thearle,MarieS;Freda,PamelaU;Bruce,JeffreyN;Isaacson,StevenR;Lee,Yoomi;Fine,RobertL
• 通讯作者: Fine,RobertL