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NCT05385419
Diagnostic Value of Bronchoscopic and Thoracoscopic Frozen Section Biopsies in Patients With Pleuropulmonary Tumors
NA trial testing Bronchoscopic and thoracoscopic frozen section biopsies in Event of Undetermined Intent (Y21-Y33) in 96 participants. Status unknown.
30 September 2023
Quick facts
| Lead sponsor | Assiut University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 96 |
| Start date | 15 June 2022 |
| Primary completion | 30 September 2023 |
| Estimated completion | 30 December 2023 |
Drugs / interventions tested
- Bronchoscopic and thoracoscopic frozen section biopsies
Conditions studied
- Event of Undetermined Intent (Y21-Y33) — all drugs for Event of Undetermined Intent (Y21-Y33) →
Sponsor
Assiut University
Who can join
Adults 18 to 75, any sex, with Event of Undetermined Intent (Y21-Y33). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Lung cancer is the second most commonly diagnosed cancer worldwide, after breast cancer, and its incidence continues to grow. Flexible bronchoscopy is the diagnostic tool of choice to diagnose endobronchial malignancies. It allows inspection and biopsy of any endobronchial abnormalities under direct vision. Despite specimens are obtained under direct vision, there is a significant failure rate. This may necessitate repeating bronchoscopy. To guide the bronchoscopist on the quality and quantity of specimens during bronchoscopic biopsies for the diagnosis of lung cancer is rapid on-site evaluation (ROSE) of cytological specimens. Intra-procedural Frozen Section Evaluation (FROSE) of bronchoscopic biopsy specimens is an alternative to ROSE and helps preventing repeated bronchoscopies. Medical thoracoscopy increases the diagnostic yield of MPE as it offers the clinician a "window" for direct visualization and collection of samples from the parietal pleura.The acquracy of frozen section biopsies in pleural tumours is largely undefined. Confirmation of the pleural malignancy can lead to immediate pleurodesis following the pleural inspection and biopsy. To our knowledge limited studies discussed the value of frozen section in both bronchoscopic and thoracoscopic biopsies.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05385419 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assiut University
- Last refreshed: 23 May 2022
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