An observational study in Lung Cancer, sponsored by Seoul National University Bundang Hospital. Recruiting at 11 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Seoul National University Bundang Hospital · Observational
The primary objective is To evaluate the usefulness and safety of advanced guided bronchoscopy for histological diagnosis of peripheral pulmonary lesions.
The Secondary objective is to establish a strategy that can most effectively use endoscopes for early diagnosis of lung cancer in a real-world care environment by identifying patient/clinical/image/procedure-related characteristics that can optimize the practicality of emerging technologies.
7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 1,240 is above the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with peripheral pulmonary lesions that require histological differentiation because of the possibility of malignancy and are scheduled for biopsy attempted through guided bronchoscopy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1) Patients who are unable to express their opinions and cannot cooperate due to a lack of cognitive function
Patients with peripheral pulmonary lesions which require histological differentiation because of the possibility of malignancy, and a biopsy can be attempted through guided bronchoscopy
Device: Guided bronchoscopy
It is performed when a pulmonary lesion with a possibility of malignancy is found on chest CT and histological diagnosis and differentiation are required.
Also known as: Device: Spin Thoracic Navigation System, Device: Radial EBUS probe
Diagnostic yield at index
The proportion of pathologic results that leads to a specific malignant or benign
Time frame: Upon reports of pathologic results (up to 2 weeks after bronchoscopy)
Diagnostic accuracy at 12 months
True positive + True negative (confirmed benign with follow-up of at least 1yr without progression) / Total procedures Pathologic results of a malignant or benign specific diagnosis based on the samples collected via index ENB procedure are categorized as true positives or true negatives. For pathologic results of a benign non-specific diagnosis and non-diagnostic results, follow-up data would be used to determine whether the 12-month status corroborates the benign results. Based on definition scenarios, these results will be determined as true negatives or false negatives. Diagnostic yields based on different scenarios will be reported.
Time frame: Confirmed by follow-up results at 1 year
Sensitivity for malignancy
True positive/Confirmed malignancy cases
Time frame: Confirmed by follow-up results at 1 year
Complication
Evaluate complications due to guided bronchoscopic biopsy
Time frame: Confirmed by follow-up results at 1 year
Plan to share: No
Started Apr 2023 (actual). Primary completion is estimated for Jul 2027, 51 months after the start.
Of 578 non-industry observational studies under Lung Neoplasms, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 172. This study's planned 51 months is below that.
Counting every sponsor, half of 685 studies reached it within 56 months; a quarter within 29 and three quarters within 130.
How these figures are worked out, and which studies are left out of them.
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