DRKS00009539
Completed
未知
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 sites11 target enrollmentOctober 22, 2015
ConditionsC01C02C04C05C06C09C10Malignant neoplasm of base of tongueMalignant neoplasm of other and unspecified parts of tongueMalignant neoplasm of floor of mouthMalignant neoplasm of palateMalignant neoplasm of other and unspecified parts of mouthMalignant neoplasm of tonsilMalignant neoplasm of oropharynx
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- C01
- Sponsor
- Charité Campus Charité Mitte
- Enrollment
- 11
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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