Lung cancer Cancer
Conditions
Interventions
Current interventions as of 18/08/2023:
STRATIFY is a study designed to evaluate the use of thoracoscopy (either LAT or VATS) in the staging and diagnosis of occult pleural metastases (OPM) in stage I
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Age
16 Years to 110 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 18/08/2023: 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) Previous primary outcome measure: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 18/08/2023: 1. Thoracoscopy results, recorded as OPM demonstrated/OPM not demonstrated (via pathology and cytology tests) 2. RFS, defined as the time from completion of lung cancer treatment (surgery, radical radiotherapy or radical chemo-radiotherapy) to documented recurrence of lung cancer or death from any cause. Treatment and Survival data will be collected from a review of clinical notes at the site and recorded in the study electronic CRF 3. OS, defined as the time from lung cancer treatment to death from any cause. Survival data will be collected from a review of clinical notes at the site and recorded in the study electronic CRF 4. LAT/VATS feasibility will be recorded as LAT/VATS complete/LAT/VATS incomplete (specify) /LAT/VATS not performed (specify). This information will be collected from a review of clinical notes at the site and recorded in the study electronic CRF, following the pre-LAT/VATS examinations such as US and x-Ray and the LAT/VATS itself Previous secondary outcome measure: 1. LAT results, recorded as: OPM demonstrated/OPM not demonstrated (via pathology and cytology tests) 2. RFS, defined as the time from completion of NSCLC treatment (surgery, radical radiotherapy or radical chemo-radiotherapy) to documented recurrence of NSCLC or death from any cause. Treatment and Survival data will be collected from review of clinical notes at site and recorded in the study electronic CRF. 3. OS, defined as the time from NSCLC treatment to death from any cause. Survival data will be collected from review of clinical notes at site and recorded in the study electronic CRF. 4. LAT feasibility will be recorded as LAT complete/LAT incomplete (specify)/LAT not performed (specify). This information will be collected from review of clinical notes at site and recorded in the study electronic CRF, following the pre-LAT examinations such as US and x Ray and the LAT itself 5. MRI Sub-study Exploratory outcome measures: Th | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed