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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).

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).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00009539
Enrollment
20
Registered
2015-10-22
Start date
2014-11-19
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C01 C02 C04 C05 C06 C09 C10

Interventions

Group 1: Test group Within the test group, two breath samples are collected. The first sample is collected prior to surgery, the second 3-4 weeks after surgery. Group 2: Control group Within the contr

Sponsors

Charité Campus Charité Mitte
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion 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 - 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

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

Design outcomes

Primary

MeasureTime frame
Detectable tumor-specific signature VOCs at diagnosis with the help of gas chromatography and mass spectrometry

Secondary

MeasureTime frame
No detectable tumor-specific signature VOCs after surgery with the help of gas chromatography and mass spectrometry

Countries

Germany

Contacts

Public ContactStefan Hartwig

Charité Campus Virchow-Klinikum

stefan.hartwig@charite.de+4939450655148

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026