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临床试验/CTRI/2024/07/070628
CTRI/2024/07/070628尚未招募不适用

Development of portable SERS setup for lung cancer screening by breath analysis

Department of Science and Technology Technology Bhavan New mehrauli road New Delhi1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年7月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
1. A portable SERS setup for lung cancer screening by breath analysis.

研究概览

简要总结

We have designed and developed a sample cell to collect volatile organic compounds (VOCs) of exhaled breath in an aqueous medium. The developed sample cell is designed to avoid sample loss or contamination and to fulfill the necessary condition to perform surface-enhanced Raman spectroscopy (SERS) experiments through plasmonic self-assembly of metallic nanoparticles to identify the VOCs of lung cancer. The above-mentioned sample cell will be utilized to collect the exhaled breath from the healthy volunteers (research scholars, faculty members, and junior engineers from the Department of Atomic and Molecular Physics) and from the lung cancer patients visiting the Department of Medical Oncology and Department of Respiratory Medicine KMC, Manipal during the OPD visits. The breath sample will be collected after at least 3 to 4 hours of fasting, and the participants are instructed to avoid smoking and alcohol consumption to avoid contamination. While collecting the breath sample, general instructions will be given to blow the breath into the sample cell through the mouthpiece; if necessary, a short demo will be given by the instructor. Immediately after completing 8 to 10 exhalations from the participants, the sample cell will be closed, and the mouthpiece and tube connected to the sample cell will be disposed of.

The collected exhaled breath in the sample cell will be subjected to the in situ SERS measurements using the developed optical setup. It comprises a 785 nm diode laser, an upright microscope, a compact CCD-spectrometer, and the sample cell discussed earlier. The obtained SERS spectra will be compared to discriminate the human breath samples of lung cancer patients from those of healthy volunteers.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Male or female Lung cancer patients with or without chronic obstructive pulmonary disease (COPD) Lung cancer with COPD is defined as those patients with confirmed lung cancer and their FEV1/FVC ratio less than 70 percent.
  • Lung cancer without COPD is defined as those patients with confirmed lung cancer and their FEV1/FVC ratio greater than 70 percent.

排除标准

  • Patients who are unable to exhale for at least 6 seconds during a spirometry-based pulmonary function test for COPD diagnosis.

结局指标

主要结局

1. A portable SERS setup for lung cancer screening by breath analysis.

时间窗: Three years

2. Provides a standardized methodology for the collection of VOCs present in human breath.

时间窗: Three years

3. Detect and measure the lung cancer VOC concentrations present in the exhaled breath of patients.

时间窗: Three years

次要结局

未报告次要终点

研究者

发起方
Department of Science and Technology Technology Bhavan New mehrauli road New Delhi
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

mahadeva prasad KS

Manipal Academy of Higher Education

研究点 (1)

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