Specimen and Data Collection for the COMBI Study: A Multi-center, Multi-national Clinical Evaluation of LIAISON® Calprotectin HD, a Novel Biomarker Combination for the Differential Diagnosis of Inflammatory Bowel Disease and Irritable Bowel Syndrome. COMBI: Combination of Markers for Bowel (IBD-IBS) Investigation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Diagnostic Performance
研究概览
简要总结
This study will evaluate how well the a new stool test can distinguish inflammatory bowel disease (IBD) from non-IBD conditions compared with standard calprotectin testing and colonoscopy findings. Participants will undergo only routine clinical care, including colonoscopy, and will provide a stool sample for testing. The study will also examine how test results relate to endoscopic, histologic, and ultrasound measures of disease activity. Findings may help determine whether the new test could reduce unnecessary colonoscopies and support future regulatory submissions.
详细描述
This study will evaluate the performance of a new stool-based laboratory test, which is designed to help identify inflammatory bowel disease (IBD). The study will compare this new test to standard fecal calprotectin testing. The goal is to determine how accurately the new assay can distinguish IBD from non-IBD conditions when compared with clinical diagnosis based on colonoscopy findings.
Participants will be individuals undergoing routine medical evaluation for symptoms suggestive of IBD. All medical care-including colonoscopy and biopsy collection (if applicable)-will follow standard clinical practice, and no additional procedures will be performed. Each participant will provide a stool sample for testing with the investigational device.
The study will also explore how the new test relates to endoscopic disease severity, microscopic inflammation in ulcerative colitis, and intestinal ultrasound findings. In addition, the study will estimate whether use of the new test could help reduce unnecessary colonoscopies.
This is a prospective, observational, multi-center study enrolling both pediatric and adult participants in the United States and internationally. Results from this study will support regulatory submissions in the United States and Europe.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide written informed consent, either personally or through a legally authorized representative
- •Capable of understanding and complying with the study's stool specimen collection procedures
- •For subjects under 18 years of age, enrollment will occur in accordance with applicable US IRB regulations, including informed consent from a parent or guardian and assent from the subject when appropriate (e.g., ages 14-17 years)
排除标准
- •History of IBD, IBS, or other chronic GI disorders
研究组 & 干预措施
Healthy (normal)
Subjects without history or signs and symptoms of IBS, IBD, or other chronic GI disorders
Diseased Cohort
Subjects under clinical evaluation for suspected IBD exhibiting persistent lower GI symptoms and undergoing endoscopic evaluation.
结局指标
主要结局
Diagnostic Performance
时间窗: 1 year
The candidate assay will be compared to standard FC testing in differentiating IBD from non-IBD cases against a predicate (IVDR comparator) device and using the clinical SOC, specifically endoscopic classification as the reference standard.
次要结局
未报告次要终点