To evaluate the value of volatile organic compounds analysis by eNose in the early detection of second primaries or metastasis (and early lesions).
ID
Source
Brief title
Condition
- Metastases
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: Identification of lung cancer, esophageal cancer or
metastasis by molecular profiling in exhaled breath and endobronchial air as
screening method in this high risk population.
Secondary outcome
Secondary outcome: Prevalence of early (microscopic) lung and esophageal cancer
in curatively treated head and neck cancer/ lung cancer patients.
Exploratory outcome: Site specific signal of pre-invasive lesions
Background summary
Given the high morbidity and mortality of clinical overt lung cancer it is
suggested that early intervention is useful based on the 80% cure rate from
longitudinal data and data from CT population based screening. The benefit of
screening for second primary lung cancer in high risk Head and Neck Cancer
patients have not been shown yet. Therefore, early detection of synchronous and
metachronous tumours might be useful as early detection might lead to early
intervention and therefore a better prognosis. New endoscopic imaging
techniques are nowadays available for detection of early (microscopic) cancer.
Volatile breathing compounds analysis has also the potential to be a
non-invasive screening technique.
Study objective
To evaluate the value of volatile organic compounds analysis by eNose in the
early detection of second primaries or metastasis (and early lesions).
Study design
The study will be a prospective trial. A total of 315 patients with previous
history of head-and-neck cancer and/or lung cancer are examined. Each patient
will undergo upon regular follow-up fluorescence scopy and CT scanning. During
bronchoscopy the bronchial tree will be inspected in the autofluorescence (AFI
mode, SAFE 3000, PENTAX, Breda, the Netherlands) The esophagus will be
inspected in the narrow band imaging (NBI) mode. Areas with abnormal
fluorescence or NBI will be documented and biopsied. Results will be compared
with volatile breathing compounds profiles obtained by exhaled air analysis and
analysis of air sampled during brochoscopy from pulmonary segments closest to
the tumor.
Study burden and risks
The bronchoscopy will be performed by an experienced pulmonologist. The main
inconvenience for the patient is a dry cough and pain at the site of the
nostril through the scoop will be introduced. These complaints are suppressed
by the use of lidocaine spray. The additional images made by confocal
bronchoscopy and the use of the electronic nose will add about 25 minuts to the
investigation.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33383.018.10 |
| Other | NTR in aanvraag |