Development of a Multiomics Assay for Use on OriColTM Sampled Rectal Mucus for Detection of Cancer and Significant Polyps in Symptomatic Patients on the Colorectal Urgent Suspected Cancer Pathway
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,600
- 试验地点
- 1
- 主要终点
- TRIOMIC - 1
研究概览
简要总结
Development of a multiomics assay for use on OriColTM sampled rectal mucus for detection of cancer and significant polyps in symptomatic patients on the Colorectal Urgent Suspected Cancer pathway.
详细描述
The primary objectives of the study are:
- Confirm the presence of established genetic, epigenetic and microbiome based biomarker signatures associated with CRC and high-risk adenoma (defined as >10mm in diameter or the presence of high-grade dysplasia) in colorectal urgent suspected cancer referrals, who are triaged for colonoscopy.
- To expand and refine the genomic, epigenetic and microbiome biomarker signature profiles associated with colorectal cancer and high-risk adenoma to identify rarer biomarkers in addition to those previously established.
- To generate indicative performance metrics, including an assessment of discriminatory power, sensitivity, specificity and negative predictive values for the clinical application of Oricol™ multiomics assay.
The Secondary Objectives of the study are:
- To assess the health economics of delivering a diagnostic service to patients referred to the urgent suspected cancer (USC) pathway via a Community Diagnostic Centre (CDC) in comparison to the current delivery mechanisms through the Two-Week Wait (TWW) pathway.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years and over
- •Patients referred from primary care to the 'urgent suspected cancer' CRC pathway during the study period.
- •Patients who provide voluntary written informed consent to participate in the study.
排除标准
- •Patients who are unable to undergo digital rectal examination (DRE).
- •Patients with peri-anal/anal symptoms that may limit DRE and proctoscopy examination and it would be clinically inappropriate to attempt to assess these patients. This may include conditions such as:
- •Patients who have undergone radiotherapy.
- •An acute or chronic anal fissure
- •Perianal haematoma
- •Acute thrombosed haemorrhoids
- •Post- operative anal stenosis
- •The presence of an obstructing anal/low rectal tumour or discomfort as a result of previous pelvic radiotherapy
- •Current pregnancy or suspicion of pregnancy.
结局指标
主要结局
TRIOMIC - 1
时间窗: 26 months
Determination of the clinical utility for stratification of colorectal cancer and high risk adenoma in a symptomatic population using hologenomic analysis.
TRIOMIC - 2
时间窗: 26 month
To expand and refine the genomic, epigenetic and microbiome biomarker signature profiles associated with colorectal cancer and high-risk adenoma to identify rarer biomarkers in addition to those previously established.
TRIOMIC - 3
时间窗: 26 months
To generate indicative performance metrics, including an assessment of discriminatory power, sensitivity, specificity and negative predictive values for the clinical application of Oricol™ multiomics assay.
次要结局
- Health Economic Assessment(26 months)