Pilot study for the evaluation, development and implementation of a breath test for the early detection of squamous cell carcinomas in the head and neck area (SCCHN).

Charité Campus Charité Mitte0 个研究点目标入组 11 人开始时间: 2015年10月22日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Ability ( verbal , physically and mentally ) to understand the nature of the study and to participate
•- Willingness to study participation
•- Completed and signed informed consent
•- Age between 18 and 70 years
•- Karnofsky - Index : 80%
•- Smoking ( > 10 pack years , > 15 cigarettes / day )
•- Regular alcohol consumption ( < 50 g / week )
•Test group ( n = 15)
•Specific inclusion criteria
•- Histologically confirmed primary PECA in the region of the oral cavity and oropharynx
•- Surgical treatment pending
•Control group ( n = 5)
•No more than die inclusion criteria described above.
•Patients in both groups should be smokers and drink alcohol regularly to achieve a homogenous collective and in order to avoid overinterpretion of VOCs emitted through smoking/alcohol.

•- Previous malignancies
•- Severe internal comorbidities (myocardial infarction, cardiomyopathy, NYHA functional class III / IV, severe COPD, renal failure, not controlled diabetes)
•- HIV infection
•- Drug addiction
•- Patients under 18 years old
•- Patients over 70 years
•- Karnofsky Index : < 80 %
•- Participation in a similar study

发起方

Charité Campus Charité Mitte