Chronic Prostatitis Collaborative Clinical Trials

慢性前列腺炎协作临床试验

• 批准号: 6683063
• 负责人: MARY F MCNAUGHTON-COLLINS
• 金额: $ 25万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-05 至 2008-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6683063
• 关键词: analgesics; antiinflammatory agents; chronic pain; clinical research; clinical trials; cooperative study; disease /disorder classification; ethnic group; experimental designs; human subject; human therapy evaluation; interdisciplinary collaboration; interstitial cystitis; male; medical outreach /case finding; patient /disease registry; patient oriented research; pelvis; prostatitis; quality of life; questionnaires; reproductive system disorder chemotherapy; reproductive system pharmacology

DESCRIPTION (provided by applicant): This application reflects a proposal from the Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH) / Harvard Medical School to become one of the Clinical Centers of the Chronic Prostatitis Collaborative Research Network (CPCRN) to develop and conduct randomized clinical trials for evaluating novel therapies in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The BWH/MGH Harvard clinical center has a history of successful recruitment and retention of CP/CPPS patients, including a substantial proportion of Latino patients, from the New England area for CPCRN 1997- 2003 - both for the Chronic Prostatitis Cohort Study and Randomized Clinical Trial. Drs. Mary McNaughton Collins and Michael O'Leary have advanced the field of CP/CPPS by helping to develop and validate the NIH-Chronic Prostatitis Symptom Index, translating the index to Spanish, evaluating the quality of life and resource utilization of men with CP/CPPS, as well as examining the epidemiology and natural history of the condition. Dr. McNaughton Collins has also performed several chronic prostatitis studies as a member of the Patient Outcomes Research Team (PORT) for Prostate Diseases and the Cochrane Collaboration. The BWH/MGH Harvard clinical center has expanded to include a multi-institutional and multi-disciplinary network of co-investigators and consultants with both content (i.e., chronic prostatitis, pain management) expertise and methodological (i.e., clinical trials, basic science, and outcomes research) training, as well as fresh sources of chronic prostatitis patients, especially newly diagnosed patients and minority patients. The new reservoirs of CP/CPPS patients include: 1) newly diagnosed CP/CPPS patients from primary care practices and medical walk-in units across the two large institutions and their neighborhood health centers, including the BWH internal medicine Spanish clinic; 2) both newly diagnosed and long-term CP/CPPS patients from the MGH Spanish urology clinic, and; 3) both newly diagnosed and long-term patients from Boston Medical Center, which is a large, inner-city academic health center providing care to a large proportion of African American patients. To assist in the recruitment and retention of Latino men, the site now includes 3 Spanish speaking medicine and urology investigators, and the Research Coordinator is taking Spanish classes to become proficient. This proposal includes a clinical trial design for consideration by the CPCRN. The multi-institutional, multi-disciplinary team from the BWH/MGH Harvard clinical center is eager to collaborate on treatment trials and ancillary studies with other CPCRN centers, the NIH/NIDDK scientific team, and the Interstitial Cystitis Clinical Trials Group.

描述（由申请人提供）： 本申请反映了布里格姆妇女医院（BWH）和马萨诸塞州总医院（MGH）/哈佛医学院提出的成为慢性前列腺炎合作研究网络（CPCRN）临床中心之一的建议，以开发和实施随机临床试验，评价慢性前列腺炎/慢性骨盆疼痛综合征（CP/CPPS）患者的新疗法。BWH/MGH哈佛临床中心在1997- 2003年的CPCRN中成功招募和保留了来自新英格兰地区的CP/CPPS患者（包括相当比例的拉丁裔患者），用于慢性前列腺炎队列研究和随机临床试验。玛丽·麦克诺顿柯林斯和迈克尔·奥利里博士通过帮助开发和验证NIH慢性前列腺炎症状指数，将该指数翻译成西班牙语，评估CP/CPPS男性的生活质量和资源利用，以及检查该疾病的流行病学和自然史，推进了CP/CPPS领域。作为前列腺疾病患者结局研究小组（PORT）和科克伦协作组的成员，McNaughton柯林斯博士还进行了几项慢性前列腺炎研究。BWH/MGH哈佛临床中心已经扩展到包括一个多机构和多学科的合作研究者和顾问网络，慢性前列腺炎，疼痛管理）专业知识和方法学（即，临床试验、基础科学和结果研究）培训，以及慢性前列腺炎患者的新鲜来源，特别是新诊断的患者和少数民族患者。新的CP/CPPS患者库包括：1）来自两个大型机构及其附近卫生中心的初级保健实践和医疗无预约单位的新诊断CP/CPPS患者，包括BWH西班牙内科诊所; 2）来自MGH西班牙泌尿科诊所的新诊断和长期CP/CPPS患者; 3）来自波士顿医疗中心的新诊断和长期患者，这是一个大型的市中心学术健康中心，为大部分非洲裔美国患者提供护理。为了帮助招募和留住拉丁裔男性，该网站现在包括3名讲西班牙语的医学和泌尿学研究人员，研究协调员正在学习西班牙语课程以精通西班牙语。该提案包括临床试验设计，供CPCRN考虑。来自BWH/MGH哈佛临床中心的多机构，多学科团队渴望与其他CPCRN中心，NIH/NIDDK科学团队和间质性膀胱炎临床试验组合作进行治疗试验和辅助研究。