Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

Biomarkers and Respiratory Omics as New CHildren Opportunities - Study of Clinical Outcomes and Predictivity Evaluation - a Multi-cohort, Multi-center Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure
Study Type: Observational
SUMMARY

The goal of this observational study is to improve the identification of biomarkers that predict disease progression and to assess the effectiveness of current therapies in children with asthma and protracted bacterial bronchitis. The main aim of the study is to evaluate the microbiome composition and diversity, cellular composition, and metabolomic profile. In addition, to assess their correlation on subsequent treatment and disease course in children with asthma, protracted bacterial bronchitis, and in those receiving inhaled glucocorticosteroids without a diagnosis of asthma. Participants will undergo fiberoptic bronchoscopy. During bronchoscopy, the performing physician will collect Bronchoalveolar lavage fluid samples for metagenomic and metabolomic analysis, as well as mucosal biopsies for histopathological evaluation.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: f
View:

• Age at the beginning of the study 0-17 years old

• Clinical indication and qualification by the attending physician for fiberoptic bronchoscopy under general anesthesia:

‣ Obstruction of the airways:

⁃ Suspicion of foreign body aspiration

⁃ Persistent stridor

⁃ Abnormal result of functional tests of respiratory system - flattening of inspiratory or expiratory curve, presence of restriction (tested vital capacity \<5 percentile) or irreversible obstruction (persistence of Tiffneau index \<5 percentile despite administration of bronchodilators)

⁃ Radiological findings located in the course of the larynx, trachea or bronchi

⁃ Persistent atelectasis on subsequent radiological examinations

⁃ Persistent cough \>4 weeks

⁃ Hemoptysis

⁃ Suspected laryngomalacia or tracheobronchomalacia

⁃ Suspected tracheoesophageal fistula

⁃ Persistent dyspnea unresponsive to anti-asthmatic treatment used for min. 2 months, with no other identifiable causes

⁃ Radiologically detected mediastinal abnormalities

⁃ Suspected presence of a vascular ring

⁃ Presence of excessive secretions that are impossible for the patient to expectorate

⁃ Fine needle biopsy of cystic lesions

• Obtained consent from patient/legal guardian for participation in the study

Locations
Other Locations
Poland
Żwirki i Wigury 63A
RECRUITING
Warsaw
Contact Information
Primary
Tomasz Kopiec, MD
tomasz.kopiec@wum.edu.pl
+48505300599
Backup
Aleksander Adamiec, MD
aleksander.adamiec@wum.edu.pl
+48606349502
Time Frame
Start Date: 2026-03-06
Estimated Completion Date: 2035-12
Participants
Target number of participants: 160
Treatments
Asthma
Children diagnosed with asthma at the baseline
Protracted Bacterial Bronchitis
Children diagnosed with Protracted Bacterial Bronchitis at the baseline
Children without asthma who have been exposed to inhaled glucocorticosteroids
Children without asthma who have been exposed to inhaled glucocorticosteroids for at least 4 weeks during the 2 months preceeding bronchoscopy
Non inflammatory causes of chronic cough
Children diagnosed with: laryngomalacia, tracheobronchomalacia adenoid hypertrophy, gastroesophageal reflux disease, habitual cough
Control group
Children without underlying diseases who undergo bronchoscopy either for suspected foreign body aspiration or as part of routine diagnostic evaluation
Related Therapeutic Areas
Sponsors
Collaborators: Medical University of Lodz, Medical University of Bialystok
Leads: Medical University of Warsaw

This content was sourced from clinicaltrials.gov