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).

Not Applicable

• Conditions: C01; C02; C04; C05; C06; C09; C10; Malignant neoplasm of base of tongue; Malignant neoplasm of other and unspecified parts of tongue; Malignant neoplasm of floor of mouth

• Registration Number: DRKS00009539
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-09-14
• Study Start: 2015-10-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 11

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
- 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.

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detectable tumor-specific signature VOCs at diagnosis with the help of gas chromatography and mass spectrometry

Secondary Outcome Measures

Name	Time	Method
o detectable tumor-specific signature VOCs after surgery with the help of gas chromatography and mass spectrometry