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临床试验/NCT04125524
NCT04125524暂停不适用

Terahertz Metamaterials for Tumour Marker Concentration Identification

Durham University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
90
试验地点
1
主要终点
Evidence of detection for any marker

研究概览

简要总结

The research the investigators plan to undertake involves the use of a metamaterial at terahertz frequencies. Serum samples will be tested using the metamaterial to determine if this method can be used to measure the concentration of tumour markers present in the sample. Patients who have been tested for CEA, LDH, CA-125, CA 19-9, CA 15-3, total-hCG and AFP will be used for both the positive and negative samples.

详细描述

The research the investigators plan to undertake involves the use of a paper substrate with a gold metamaterial on top or a plastic substrate with gold metamaterial on top in physical contact with paper. The metamaterial has an absorption peak within the terahertz frequency range to be investigated (0.75 - 1.1THz). The serum samples will be soaked into the paper fibres which will shift the absorption peak within the terahertz frequency range dependent on the concentration of tumour markers present in the sample. The serum samples will be surplus from samples tested for CEA, LDH, CA-125, CA 19-9, CA 15-3, total-hCG and AFP at the Durham and Darlington NHS Fondation Trust. The samples will be anonymised with the exception of which tumour marker they were tested for and the level measured.

There will be two stages to this research project the initial stage requires 15 samples per proposed marker including 15 samples (across all markers) for negative results. This will be used to identify suitable markers to consider for the second stage. Where 50 to 90 samples of each qualifying marker will be tested dependent on the number required for statistical confidence in stage two with 10 to 18 negative samples required for each qualifying marker, again dependent on the statistical requirements for each marker.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient recommended by their health professional to be tested for any of the tumour markers being studied at County Durham and Darlington NHS Foundation Trust for any reason.

排除标准

  • Patients with known bloodborne pathogens.

结局指标

主要结局

Evidence of detection for any marker

时间窗: 18 months

Any correlation showing a difference between samples with marker concentrations above and below the standard threshold values used for tests within the NHS.

次要结局

  • Quantifying the quality of detection per marker(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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