ISRCTN13189452进行中（未招募）未知
Mechanisms and Origins of Spectral Signatures: defining colorectal cancer/polyp/adenoma detection by Raman spectroscopy
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years old and over
- •2. For sub-study A (Metabolomics), informed consent has been obtained for RAMAN-CRC (Groups 1-4) and provided blood serum for Raman spectroscopy and has a corresponding tissue biopsy or resection collected as the standard of care in archives
- •3. For sub-study B (Gut microbiome):
- •3.1. Has a confirmed diagnosis of colorectal cancer, benign/inflammatory conditions requiring surgery/biopsies at colonoscopy OR normal colonoscopy/previous history of complete surgical removal of colon and rectum for the control group
- •3.2. Informed consent obtained for the RAMAN-MOSS study
- •3.3. Able and willing to provide blood serum and faecal samples
- •3.4. Corresponding tissue biopsy/resection collected as the standard of care (for CRC and benign/inflammatory bowel disease groups only)
- •4. For sub-study C (Fasting state study):
- •4.1. Has a confirmed diagnosis of CRC (for CRC group)
- •4.2. Has normal colonoscopy (for the control group)
- •4.3. Informed consent obtained for the RAMAN-MOSS study
- •4.4. Able and willing to undergo oral glucose tolerance test
- •4.5. Able and willing to provide blood serum samples for Raman spectroscopy
- •5. For sub-study D (Lipid study):
- •5.1. Known diagnosis of hyperlipidaemia and referred to hyperlipidaemia clinic
- •5.2. Informed consent obtained for the RAMAN-MOSS study
- •5.3. Able and willing to provide blood serum sample for Raman spectroscopy
- •6. For sub-study E (Bowel preparation and Antibiotics study):
- •6.1. Referred for colonoscopy for investigation of bowel symptoms OR under colonoscopy surveillance programme OR undergoing surgical resection
- •6.2. Fit for bowel preparation
- •6.3. Informed consent obtained for the RAMAN-MOSS study
- •6.4. Able and willing to provide blood serum and faecal samples
排除标准
- •1. Aged 17 years old and under
- •2. Unwilling/unable to consent to trial participation
- •3. Patients from vulnerable groups (defined as lacking the capacity to freely give informed consent)
- •4. Unwilling/unable to provide blood/faecal/tissue samples required for the study
- •5. Additional for sub-study C (Fasting state):
- •5.1. Glucose tolerance test (OGTT) contraindicated
- •5.2. Diagnosis of diabetes
- •6. Additional for sub-study E (bowel preparation and antibiotics):
- •6.1. Unfit for bowel preparation or colonoscopy
- •6.2. Allergy to bowel preparation and/or antibiotics
研究者
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