Diagnostic Accuracy of an Electronic Nose as Compared to Combined Conventional CT-Scanning, Autofluorescense Scopy for the Detection of Early Endobronchial Squamous Cell Cancer after prior History of Head-and-neck Cancer or Lung Cancer
- Conditions
- Early Endobronchial Squamous Cell Cancer1002747610029107
- Registration Number
- NL-OMON36533
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 315
Inclusion Criteria
* Patients who received a curative treatment for head-and-neck or lung cancer, including all tumour stages.
* Curative treatment > 1year ago
* Smoker or ex-smoker
* Age > 18
* Written informed consent.
Exclusion Criteria
* Residual cancer or recurrence at the time of screening with standard screening methods.
* Contraindications to bronchoscopy, as noted in the Dutch consensus guideline *bronchoscopy* (2003)
* Prior bronchoscopy with local treatment in the preceding two years.
* Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives.
* Uncontrollable bleeding tendency.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome: Identification of lung cancer, esophageal cancer or<br /><br>metastasis by molecular profiling in exhaled breath and endobronchial air as<br /><br>screening method in this high risk population.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome: Prevalence of early (microscopic) lung and esophageal cancer<br /><br>in curatively treated head and neck cancer/ lung cancer patients.<br /><br><br /><br>Exploratory outcome: Site specific signal of pre-invasive lesions</p><br>