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临床试验/NCT01527461
NCT01527461Unknown不适用

Identifying Unique Scent Signature of Lung Cancer Through Body Odor

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Number of patients with lung neoplasms

研究概览

简要总结

The purpose of this study is to show that dogs are able to detect cancer in sweat samples. This potentially would be the base for developing a new efficient, non invasive and inexpensive diagnosis tool of lung cancer.

详细描述

Among all cancers which harm the population, lung cancer is the most lethal type, responsible for 1.3 million deaths per year worldwide, for 28% of all cancer deaths.The 5 year survival rates are low, only 15%.

Diagnosis and treatment of lung cancer in its early stages could increase the 5-year-survival rate by 3-4 fold with a potential for cure. Therefore, efforts are being made to develop new sensitive specified screening tools for detecting lung cancer at its' earliest stages.

A new emerging strategy for early detection of lung cancer is based on the recognition of the tumors metabolic signature, on the identification of specific biomarkers for the disease, such as the volatile organic compounds (VOC). Research has demonstrated that these compounds are released from the cancerous tissue from the early stages of the disease, and can be found in different bodily secretions.

The subjects, lung cancer patients and chronic obstructive pulmonary disease (COPD) patients, would be given cotton T-shirts with instructions to wear them without previously applying deodorant or any other similar personal hygiene products. Then, the shirts would be collected and 8 pieces (size:1cm*3cm from the armpit areas) would be cut from each one.

Dogs for this study would be trained by the "Dogs for People" association. In the initial stage, 40 mixed breed dogs and 3-4 Springer spaniels would be exposed to sweat sample collected from cancer patients in order to get them acquainted with the scent. Then, it would be demanded of them to locate boxes containing T-shirt sample taken from cancer patients, from decoy boxes holding naïve T-shirts. Every sequence will include 4 boxes with a different ratio between the specimens(each time a different number of boxes will contain samples taken from cancer patients, 0,1,2,3 or 4 when the rest of the boxes would contain naïve T-shirts). The dogs would mark the specimen by sitting next to each relevant box (they will ignore the decoy boxes after sniffing them and identifying them as irrelevant).

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • A diagnosis of lung cancer, regardless of histology.
  • Exclusion Criteria
  • Inability to comply with study and/or follow up procedure.
  • Co morbidity of lung cancer and an additional malignancy combined.
  • Patients taking part in another clinical trial and receiving any treatment for it.

排除标准

  • 未提供

结局指标

主要结局

Number of patients with lung neoplasms

时间窗: one year

Dogs ability to distinguish between COPD and lung cancer patients sweat samples

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Nir Peled MD, PhD

Head, Thoracic Cancer Research and Detection Center,Tel Hashomer, Israel

Sheba Medical Center

研究点 (1)

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