NCT02940054Unknown不适用
Validation of the RED-FLAGS Index for Early Diagnosis of Crohn's Disease: Prospective Observational Study
Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2015年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Sensibility of the Red Flags Index
研究概览
简要总结
Observational prospective study to validate a new index for early diagnosis of Crohn's disease (CD)
详细描述
The study will be conducted in Italian referral centers for Crohn's disease and will involve general practitioners (GPs) for RED-Flags Index validation.
The project is divided into two phases.
- retrospective phase (4 weeks). All the general practitioners participating to the study will extrapolate from their patient's database, the total number of patients with a Crohn's disease diagnosis performed in the past. The date of diagnosis will be indicated. No other information will be provided. These data will be then analyzed to obtain, for each GP, the total number of CD diagnosed in each semester.
- retrospective phase (6 months). GPs will administer the RED-Flags questionnaire to all patients that meet inclusion and exclusion criteria, after informed consent signature. All these patients will be then referred to the nearest referral center, to be evaluated by a gastroenterologist specialized in CD, to confirm or exclude a CD.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least one of the following symptoms, for at least 4 weeks (either continuous or intermittent)
- •diarrhea (>3 bowel movements per day)
- •nocturnal diarrhea
- •weight loss (≥5% of usual body weight)
- •abdominal pain (chronic or intermittent)
- •perianal lesions or fistulae or perianal abscess (hemorrhoidal diseases excluded)
- •In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
排除标准
- •known diagnosis of Crohn's disease, ulcerative colitis, chronic diverticulosis or any other gastrointestinal disease
- •any clinical condition that, in the opinion of the investigator, can alter stud results
- •inability to understanding and complying with protocol requirements
- •informed consent not signed and dated by the subject
结局指标
主要结局
Sensibility of the Red Flags Index
时间窗: at enrollment
Sensibility, specificity, accuracy, positive and negative likelihood ratio measurement
次要结局
- Cut-off for Crohn's disease diagnosis(at enrollment)
- Percentage of early diagnosed(6 months of prospective period)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn DiseaseCrohn DiseaseNCT01183845Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives24
已完成
3 期
Capsule Endoscopy Crohn's Disease Activity Index - Validation Multi Center StudyCrohn's DiseaseNCT00596700Rabin Medical Center100
招募中
不适用
Validation of biomarkers for Crohn*s disease using peripheral blood cells of patientsulcerative colitiscrohn's diseaseNL-OMON48615Vrije Universiteit Medisch Centrum200
终止
不适用
The Biologic Onset of Crohn's Disease: A Screening Study in First Degree RelativesGenetic PredispositionIBDCrohn DiseaseNCT03291743Carilion Clinic38
进行中（未招募）
不适用
Validation and Interobserver Reliability of a Simple Ultrasound Score for Crohn's DiseaseUltrasoundCrohn DiseaseNCT03481751Haukeland University Hospital124