A COMPREHENSIVE MODEL OF SEVERITY IN OUTCOMES IN ANKYLOSING SPONDYLITIS
A COMPREHENSIVE MODEL OF SEVERITY IN OUTCOMES IN ANKYLOSING SPONDYLITIS
批准号:
8174433
负责人:
MICHAEL H. WEISMAN
金额:
$21.19万
依托单位国家:
美国
项目类别:
财政年份:
2009
资助国家:
美国
项目状态:
已结题
起止时间:
2009-12-01 至 2010-11-30
关键词:
AffectAliquotAnkylosing spondylitisArthritisBiological MarkersBloodBlood specimenC-reactive proteinCaliforniaCervical spineChronicClinical DataClinical ResearchComputer Retrieval of Information on Scientific Projects DatabaseConsentConsultCountryDiagnosisDiseaseEnrollmentFractureFundingFutureGenotypeGrantInflammationInstitutionJointsLaboratoriesLateralLengthLinkMailsMeasurementMeasuresModelingOsteoporosisOutcomePainParticipantPatientsPelvisPeripheralPersonsPhysical ExaminationPlasmaPredispositionPrevalencePrincipal InvestigatorQuestionnairesRecruitment ActivityResearchResearch PersonnelResourcesRheumatoid ArthritisRiskSan FranciscoScreening procedureSedimentation processSeveritiesSiteSourceSpinalSpinal cord injuryTestingTexasTimeUnited States National Institutes of HealthUniversitiesVenous blood samplingVertebral columnVisitWomanboneflexibilityfollow-upmenpsychosocial adjustmentradiologistwardyoung adult
中文摘要
这个子项目是许多研究子项目中的一个
由NIH/NCRR资助的中心赠款提供的资源。子项目和
研究者(PI)可能从另一个NIH来源获得了主要资金,
因此可以在其他CRISP条目中表示。所列机构为
研究中心,而研究中心不一定是研究者所在的机构。
强直性脊柱炎(AS)是一种慢性炎症性关节炎,主要影响骨盆和脊柱关节。这些关节的炎症会导致疼痛、僵硬和脊柱灵活性的限制。随着时间的推移,发生关节融合,导致脊柱完全不动,继发性骨质疏松症,以及骨折和脊髓损伤的风险。外周关节也可能受累。AS的患病率为1:1000人,并且主要开始于青年期。男性的患病率是女性的3倍。AS是与HLA基因座中的任何标记最紧密相关的疾病,并且对AS的易感性在很大程度上由遗传决定。
合格患者将同时进行筛选和基线访视,届时研究者将确认其AS诊断,完成背景信息问卷和疼痛量表,并进行静脉切开术。此时,他们将被要求:1。)完成关节炎活动问卷; 2.)完成心理社会适应问卷; 3.)对他们的关节进行身体检查并测量脊柱的灵活性; 4.)抽取50 ml血液用于基因分型; 5.)抽血检测血沉(血沉)和CRP(C反应蛋白)。两者都是炎症的指标; 6。有骨盆(AP视图)、腰椎(AP和侧视图)和颈椎(侧视图)的X线照片。
入组PSOAS研究的患者将继续接受本研究的随访。此外,我们计划在全国4个不同的研究中心入组约360例新获得和招募的患者:CSMC、加州大学旧金山分校弗朗西斯科、德克萨斯大学休斯顿分校和美国国立卫生研究院。在CSMC,我们计划招募120名患者。
当受试者到达一般临床研究中心进行筛选/基线访视时,主要研究者将同意受试者参加研究。
随访访视将在基线访视后每6个月进行一次,并持续每例患者的研究时间。在本研究的时间范围内,患者的随访期长度将从2年到7年不等,因为我们将随访既往入组的患者以及新获得的患者。在每次访问时,参与者将完成关节炎活动问卷,心理社会适应问卷,检查他们的关节和测量脊柱的灵活性,并抽血测定沉降率和C反应蛋白(炎症的测量)。每24个月重复一次X线片检查。
将在入组中心进行静脉切开术和X线片检查。
本研究获得的所有血液样本将送至德克萨斯大学休斯顿分校的John Reveille博士进行分析。ESR和CRP检测将在商业实验室进行。将用于未来生物标志物分析的血清和血浆等分并储存在每个研究中心的-70 ℃冰柜中,以供未来分析。所有的调查问卷和临床数据将被发送给迈克尔·沃德博士在NIH进行分析。X光片将以数字方式拍摄,通过CD邮寄给CSMC,并由南加州大学的骨放射学咨询师托马斯·卢恩博士进行评分。
英文摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
Ankylosing spondylitis (AS) is a chronic inflammatory arthritis that primarily affects the joints of the pelvis and spine. Inflammation in these joints causes pain, stiffness, and limitations in spinal flexibility. Over time, fusion of the joints occurs, leading to complete spinal immobility, secondary osteoporosis, and risk of fracture and spinal cord injury. Peripheral joints may also be involved. The prevalence of AS is 1:1000 persons, and it primarily begins in young adulthood. Men are affected 3 times more often than women. AS is the disease most tightly linked to any marker in the HLA locus, and susceptibility to AS is largely genetically determined.
Eligible patients will undergo a simultaneous screening and baseline visit at which time their diagnosis of AS will be confirmed by the study investigators, a Background Information Questionnaire and pain scale will be completed, and phlebotomy will be performed. At this time they will be asked to: 1.) complete an Arthritis Activity Questionnaire; 2.) complete a Psychosocial Adjustment Questionnaire; 3.) have a physical examination of their joints and measurements of spinal flexibility; 4.) have 50 ml of blood drawn for genotyping; 5.) have blood drawn for ESR (sedimentation rate) and CRP (C-Reactive Protein). Both are measures of inflammation; 6.) have radiographs of the pelvis (AP view), lumbar spine (AP and lateral views), and cervical spine (lateral view).
Patients that have been enrolled in the PSOAS study will continue to be followed in this study. In addition, we plan to enroll approximately 360 patients newly acquired and recruited for this study at 4 different sites around the country: CSMC, University of California at San Francisco, University of Texas at Houston and the National Institutes of Health. At CSMC, we plan to enroll 120 of those patients.
Subjects will be consented for participation by the Principal Investigator when they arrive for their screening/baseline visits in the General Clinical Research Center.
Follow-up visits will occur every 6 months after the baseline visit and continue for the length of the study for each patient. Patients will vary in the length of the follow-up period from 2 to 7 years during the time frame of this study because we will be following previously enrolled patients as well as newly acquired patients. At each visit, participants will complete the Arthritis Activity Questionnaire, the Psychosocial Adjustment Questionnaire, have an examination of their joints and measurements of spinal flexibility, and have blood drawn for sedimentation rate and C-reactive protein (measures of inflammation). Radiographs will be repeated every 24 months.
Phlebotomy and radiographs will be performed at the enrolling center.
All blood samples obtained for this study will be sent for analysis to Dr. John Reveille at the University of Texas at Houston. Testing of ESR and CRP will be done at a commercial laboratory. Serum and plasma for future biomarker analyses will be aliquoted and stored in a -70C freezer at each site for future analysis. All questionnaire and clinical data will be sent to Dr. Michael Ward for analysis at the NIH. Radiographs will be taken digitally, mailed to CSMC on CD and scored by Dr. Thomas Learch, the consulting bone radiologist from USC.
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