NCT07208201

Brief Summary

Interstitial lung disease (ILD) represents a various group of disorders characterized by inflammation and fibrosis within the lung parenchyma.\[1\] ILD refers to a group of diffuse parenchymal lung disorders, including a spectrum of conditions such as idiopathic pulmonary fibrosis (IPF), sarcoidosis, and connective tissue disease-associated ILD (CTD-ILD) characterized by inflammation and fibrosis of the interstitium. ILD results in Impaired lung function and, in severe cases, respiratory failure.\[1\] Diagnosing ILD is a complex task due to the heterogeneous nature of these disorders. Distinguishing between different ILD subtypes and identifying disease progression present ongoing challenges in clinical practice. .\[2\] BAL emerges as a key investigative tool , allowing for the collection of bronchoalveolar fluid. The cellular and molecular composition of BAL fluid provides valuable insights into the underlying pathology, aiding in the differential diagnosis of ILD subtypes. The gold standard in BAL analysis is cytological examination by microscopy.\[3\] Flow cytometry is an updated method of BAL analysis which can provide quicker and more objective results and, with the appropriate design of antibody panels, accurately quantify the main leukocyte subsets. Several studies have described the usefulness of flowcytometry for the discrimination of sarcoidosis from other lymphocytic pathologies or even to perform leukocyte subset counting in diverse ILDs.\[4\]\[5\] Both microscopic and flowcytometric examination of BAL in ILD are complementary tools that provide comprehensive information about the cellular landscape of the lower respiratory tract ,conclusive for: Accurate diagnosis Primary aim: Characterization of specific inflammatory cellular infiltrate in different interstitial lung diseases. \- Secondary aims:

  1. 1.Correlation between clinical ,radiological and inflammatory cellular pattern as regards BAL findings of different interstitial lung diseases
  2. 2.Assessment of impact on outcome, prognosis and survival of the disease as regards management modification after BAL characterization

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
18mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

September 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 4, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2027

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 1, 2025

Last Update Submit

September 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • description of pattern and percentage of specific inflammatory cellular infiltrate in different interstitial lung diseases in bronchoalveolar lavage .

    2 years

Interventions

bronchoscopyPROCEDURE

BAL is performed with the fiberoptic bronchoscope in a wedge position within the selected bronchopulmonary segment. The total instilled volume of normal saline should be no less than 100 ml and should not exceed 300 ml. Three to five sequentially instilled aliquots are generally withdrawn after each aliquot instillation. For optimal sampling of distal airspaces, the total volume (pooled aliquots) retrieved should be greater than or equal to 30% of the total instilled volume. A total volume of retrieved fluid less than 30% may provide a misleading cell differential, especially if total retrieved volume is less than 10% of total instilled volume. If less than 5% of each instilled aliquot volume is recovered during the procedure due to retention of most of the fluid in the lavaged segment, the procedure should be aborted to avoid increased risk of tissue disruption and/or inflammatory mediator release due to overdistention of the lavaged segment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subtypes of interstitial lung diseases

You may qualify if:

  • Age ≥ 18 years
  • Clinical suspicion of ILD based on symptoms, clinical examination, and radiological findings or newly diagnosed cases .
  • HRCT findings consistent with ILD
  • Willingness to undergo bronchoscopy with BAL and provide informed consent

You may not qualify if:

  • Hemodynamic instability or ICU admission at time of evaluation
  • Oxygen saturation \< 88% on room air or \< 92% on oxygen therapy
  • Absolute contraindications to bronchoscopy (e.g., uncorrected bleeding diathesis, recent myocardial infarction)
  • Associated chronic chest diseases other than ILD (COPD. bronchial asthma and lung cancer )
  • Known active pulmonary infection or recent antibiotic treatment (\< 2 weeks)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
pulmonologist at Assiut Police hospital

Study Record Dates

First Submitted

September 1, 2025

First Posted

October 6, 2025

Study Start

December 4, 2025

Primary Completion (Estimated)

December 4, 2026

Study Completion (Estimated)

December 4, 2027

Last Updated

October 6, 2025

Record last verified: 2025-09