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Diagnostic Accuracy Study for OWL-EVO1 as a Lung Cancer EVOC® Probe
EU CTIS ID: 2023-503574-20-00
What this study is testing
Diagnostic accuracy: To assess diagnostic accuracy of the OWL-EVO1 Breath Biopsy test (OBBT) to differentiate between individuals with relevant clinical presentations in which the test is intended to be used (lung cancer and contrast groups representing clinical presentation that include lung cancer as part of its differential diagnosis). In this context relevant clinical presentations means: Individuals eligible for lung cancer screening based on low dose CT with or without lung cancer. Incidental findings on CT-scan suspicious of lung cancer Clinical presentations which include lung cancer as part of their differential diagnosis
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 45-85 years
- Ability to provide informed consent
- BMI 16 - <40
- Receiving a CT including the thoracic region, within the last 6 months
You likely can't join if
- (Anticipated) inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation unaided or claustrophobia).
- Potential subjects if in the opinion of the investigator lack mental capacity
- Received an investigational medical product in the context of a Clinical Trial (CTIMP) during the 28 days prior to administration of the (first) probe, or within 5 times the half-life of the investigational medicinal product previously received, whichever is longer
- Individuals under diagnostic investigation for a potential malignancy other than lung cancer that has not yet reached a conclusive diagnosis
- Individuals with an inconclusive lung abnormality (indeterminate pulmonary nodule) on CT-scan requiring CT-based monitoring rather than biopsy and/or treatment
- Documented history of pulmonary surgery or endobronchial interventional procedures other than biopsy, lavage, or bronchial brushings. These include surgical resection, Video Assisted Thoracic Surgery (VATS), bronchial thermoplasty and coiling, airway stenting or other interventional bronchoscopic procedures
See the full eligibility criteria
- Aged 45-85 years
- Ability to provide informed consent
- BMI 16 - <40
- Receiving a CT including the thoracic region, within the last 6 months
- (Anticipated) inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation unaided or claustrophobia).
- Potential subjects if in the opinion of the investigator lack mental capacity
- Received an investigational medical product in the context of a Clinical Trial (CTIMP) during the 28 days prior to administration of the (first) probe, or within 5 times the half-life of the investigational medicinal product previously received, whichever is longer
- Individuals under diagnostic investigation for a potential malignancy other than lung cancer that has not yet reached a conclusive diagnosis
- Individuals with an inconclusive lung abnormality (indeterminate pulmonary nodule) on CT-scan requiring CT-based monitoring rather than biopsy and/or treatment
- Documented history of pulmonary surgery or endobronchial interventional procedures other than biopsy, lavage, or bronchial brushings. These include surgical resection, Video Assisted Thoracic Surgery (VATS), bronchial thermoplasty and coiling, airway stenting or other interventional bronchoscopic procedures
- Pregnant or breastfeeding women and women of child-bearing potential not using adequate contraceptive methods (Subjects must agree to use contraception for 2 months post last dose)
- Individuals under investigation for suspicion of lung cancer who are unlikely to receive a definitive tissue diagnosis of lung cancer prior to treatment (e.g. stereotactic ablative radiotherapy without tissue confirmation)
- Further to the above stated exclusion criteria, in the interest of subject safety, exclusion of any subject is at the ultimate discretion of the investigator. This includes (but is not limited to) subjects who are acutely unwell according to investigator assessment.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.