Clinical trial · Observational
Follow-up Modalities of Low Grade Precancerous Bronchial Lesions
Endoscopic Follow-up of Low Grade Precancerous Bronchial Lesions in High Risk Patients (SELEPREBB1)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this multicentric French randomized trial is to determine the best auto fluorescence bronchial endoscopic follow-up strategy in high risk patients bearing low grade bronchial precancerous lesions. Subjects will be randomly assigned to one of the following arm : (A) every 6 months clinical and chest Xrays follow-up without intermediate endoscopy, (B) every 6 months clinical and chest Xrays follow-up including repeated autofluorescence endoscopy and biopsies on a 6 months basis in case of low grade dysplasia or on a one year basis in patients without dysplasia. After 36 months follow-up, each patient from the two groups will be subjected to a final autofluorescence endoscopy and biopsy and a Spiral Chest Xray. The final analysis will compare between the two groups : 1. The probability of progression from an initially identified low grade lesion to a high grade lesion 2. The probability of respiratory epithelial tract progression assessed by the occurrence of a lung cancer or high grade lesion. 3. The characteristics of lung cancers detected in each arm 4. In both arm, the influence of risk factors and persistent exposure to tobacco on lesion evolutivity.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precancerous Conditions | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Thoracic Neoplasms | Thoracic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- occurence of high grade lesion or occurence of a cancer during endoscopic or clinical follow up
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with one or several of the following risk factor for lung cancer: * Tobacco consumption more than 30 pack years * Lung or ENT cancer history, cured * Occupational exposure to respiratory carcinogens * Normal baseline CT scan * Autofluorescence endoscopy showing moderate dysplasia or lower grade lesion * Written informed consent Exclusion Criteria: * Treatment with Vit A derivative * Contra indication for a fiberoptic bronchoscopy under local anesthesia. * Known evolutive cancer * Chest radiation therapy within 5 years before inclusion or chemotherapy within two years before inclusion. * Impossibility for a 3 years follow-up
References
Publications (3)
- RESULTThiberville L, Moreno-Swirc S, Vercauteren T, Peltier E, Cave C, Bourg Heckly G. In vivo imaging of the bronchial wall microstructure using fibered confocal fluorescence microscopy. Am J Respir Crit Care Med. 2007 Jan 1;175(1):22-31. doi: 10.1164/rccm.200605-684OC. Epub 2006 Oct 5. PMID 17023733
- DERIVEDGuisier F, Deslee G, Birembaut P, Escarguel B, Chapel F, Bota S, Metayer J, Lachkar S, Capron F, Homasson JP, Taulelle M, Quintana M, Raspaud C, Messelet D, Benzaquen J, Hofman P, Baddredine J, Paris C, Cales V, Laurent P, Vignaud JM, Menard O, Copin MC, Ramon P, Bouchindhomme B, Tavernier JY, Quintin I, Quiot JJ, Galateau-Salle F, Zalcman G, Piton N, Thiberville L. Endoscopic follow-up of low-grade precancerous bronchial lesions in high-risk patients: long-term results of the SELEPREBB randomised multicentre trial. Eur Respir J. 2022 Sep 15;60(3):2101946. doi: 10.1183/13993003.01946-2021. Print 2022 Sep. PMID 35236723
- DERIVEDSalaun M, Roussel F, Bourg-Heckly G, Vever-Bizet C, Dominique S, Genevois A, Jounieaux V, Zalcman G, Bergot E, Vergnon JM, Thiberville L. In vivo probe-based confocal laser endomicroscopy in amiodarone-related pneumonia. Eur Respir J. 2013 Dec;42(6):1646-58. doi: 10.1183/09031936.00191911. Epub 2012 Sep 27. PMID 23018901