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临床试验/NCT04217083
NCT04217083Unknown不适用

Volatile Organic Compounds (VOCs) Could Discriminate Patients With Colorectal Cancer From Healthy Controls.

Societa Italiana di Chirurgia ColoRettale1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年1月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
Test Sensitivity and specificity for colorectal cancer

研究概览

简要总结

Volatile organic compounds (VOCs) are low molecular weight (<1 kDa) compounds which represent the final products of cell metabolism. Their composition can be affected by several factors including diet, hormones, environment and the presence of diseases, in particular, cancer.

Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality.

The expression of VOCs in breath that are linked to a patient's disease state could offers a powerful, non-invasive approach to identifying CRC patients.

详细描述

Volatile organic compounds (VOCs) are low molecular weight (<1 kDa) compounds which represent the final products of cell metabolism. Their composition can be affected by several factors including diet, hormones, environment and the presence of diseases, in particular, cancer.

Endogenous breath VOCs can originate anywhere in the body, reversed in the venous blood stream and than to the lung alveoli where some of them are exhaled .

Alteration in VOC production in patients with cancer has been postulated to relate to (per)oxygenation of cell membrane-based polyunsaturated fatty acids resulting from genetic and/or protein mutations within tumour cells and the increased relative prevalence of reactive oxygen species within cancer cells. VOCs consist largely of benzene, alkanes and aldehydes (or their derivatives), and several studies have demonstrated that various cancers, including lung and breast cancer,melanoma, mesothelioma and hepatocellular carcinoma, are associated with specific VOC profiles that differ from normal.

Volatile organic compounds are present in various excreted biological materials (urine, blood, faeces an breath) and their analysis offers a possibility for cancer screening.

Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of cancer-related mortality. It is the second leading cause of cancer-related death in Europe and the third in the USA.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 95
  • Histologically proven colorectal cancer
  • Patient with single or multiple polyps of the colon
  • Healthy subjects with negative colonoscopy
  • Patients already sampled and operated for colorectal cancer with no sign of recurrence
  • Written informed consent

排除标准

  • Pregnancy
  • Inflammatory bowel disease
  • Synchronous cancers
  • Liver and/or lung metastasis
  • Bowel prep
  • Recurrent CRC
  • Any psychiatric disease
  • Emergency operations

结局指标

主要结局

Test Sensitivity and specificity for colorectal cancer

时间窗: 30 days

A specificity of 80% and a sensitivity of 90% will be considered reliable

次要结局

  • Test Sensitivity and specificity for colorectal polyps(30 days)

研究者

发起方
Societa Italiana di Chirurgia ColoRettale
申办方类型
Network
责任方
Sponsor

研究点 (1)

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