STRATIFY: Staging by thoracoscopy in potentially radically treatable non-small cell lung cancer associated with minimal pleural effusio
- Conditions
- ung cancerCancer
- Registration Number
- ISRCTN13584097
- Lead Sponsor
- HS Greater Glasgow and Clyde
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37996118/ (added 24/11/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 50
Current participant inclusion criteria as of 18/08/2023:
1. Suspected or confirmed stage I-IIIA lung cancer
2. Mini-PE, defined as an ipsilateral pleural effusion, resulting in < 1/3 hemithorax opacification on erect chest radiograph which is either:
2.1. Too small to safely aspirate after US assessment (level 1 operator judgement)
2.2. Cytology-negative after diagnostic aspiration
3. Performance Status 0-2
4. Radical treatment feasible (Surgery, Radical RT or chemo-RT, +/- immunotherapy)) if OPM is excluded by thoracoscopy (local PI judgement)
5. Aged 16 or over
6. Informed written or remote consent
7. Willingness to comply with scheduled visits, study procedures and laboratory tests
Previous participant inclusion criteria:
Eligibility Criteria for the Main Study
1. Stage I-IIIA NSCLC, after completion of routine staging
2. Mini-PE, defined as an ipsilateral pleural effusion, which is = 40 mm in max depth on axial CT scan and either:
2.1 Too small to safely aspirate after US assessment (level 1 operator judgement)
2.2 Cytology-negative after diagnostic aspiration
3. Performance Status 0-2
4. Radical treatment feasible (Surgery, Radical RT or chemo-RT) if OPM excluded by LAT (MDT judgement)
5. Aged 16 or over
6. Informed written consent
7. Willingness to comply with scheduled visits, study procedures and laboratory tests
Eligibility Criteria for the MRI sub-study
1. Registered to the main STRATIFY study
2. Informed written consent
3. Willingness to comply with scheduled visits, and study procedures
Current Participant exclusion criteria as of 18/08/2023:
1. Any metastatic disease, including confirmed pleural metastases
2. Any contraindication to the selected thoracoscopy method when LAT is the preferred method:
2.1. Absent lung sliding or extensive fluid loculation on pleural ultrasound (not applicable to VATS) when VATS is the preferred method:
2.2. Insufficient fitness for general anaesthesia (not applicable to LAT)
3. Uncorrectable bleeding disorder (applicable to LAT and VATS)
Previous participant exclusion criteria:
Main study:
1. Any metastatic disease, including confirmed pleural metastases
2. Bilateral pleural effusions
3. Any contraindication to LAT, e.g.:
3.1 Absent lung-sliding on pleural ultrasound
3.2 Uncontrollable cough
3.3 Uncorrectable bleeding disorder
MRI Sub-study Exclusion Criteria
1. Any contraindication to MRI, including but not limited to:
1.1 Claustrophobia, pregnancy
1.2 Metallic foreign body
1.3 Pacemaker/implant
1.4 Allergy to Gadolinium contrast
1.5 eGFR <30 ml/min
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measure as of 18/08/2023:<br> The true prevalence of detectable OPM, as defined by the proportion of recruited patients with lung cancer cells in parietal pleural biopsies (pathology) or pleural fluid (cytology) obtained during Thoracoscopy (LAT or VATS)<br><br><br><br><br> Previous primary outcome measure:<br> The true prevalence of detectable OPM, as defined by the proportion of recruited patients with NSCLC cells in parietal pleural biopsies (pathology) or pleural fluid (cytology) obtained during Local Anaesthetic Thoracoscopy, at visit 3<br>
- Secondary Outcome Measures
Name Time Method