Microbial Colonization in Lung Cancer Patients

Recruiting

• Conditions: Microbial Colonization

• Registration Number: NCT05748795
• Lead Sponsor: Assiut University

Brief Summary

Primary Aim:

-To determine the prevalence and pattern of bronchial colonization in patients presenting with lung cancer at the time of diagnosis

Secondary Aim:

-To assess the potential demographic, clinical, radiological and histological predictors of colonization in patients with lung cancer

Detailed Description

Lung cancer is the world's most common neoplasm and its incidence is rising. Lung cancer has the highest mortality rates of all cancers. Pulmonary infections, especially pneumonia, frequently complicate the course of lung cancer and are often the ultimate cause of death.

It has been suggested that bronchial colonization plays a key role in the establishment of pulmonary infections in patients with lung cancer, and thus clearly influences the therapeutic management and probably the prognosis of cancer.

In such patients, colonization may arise following local bronchial impairment, e.g. stenosis or impaired mucociliary clearance, or be caused by more general abnormalities, including immunosuppression, malnutrition, smoking, chronic obstructive pulmonary disease (COPD) and chemotherapy. Studies indicate that bronchial colonization can be demonstrated in 48.1% of patients with lung cancer and may be caused by potential pathogenic microorganisms (PPMs), mainly Haemophilus influenzae, Streptococcus pneumoniae and Staphylococcus aureus. Other potential microbial agents, such as mycobacteria and fungi, have not been investigated systematically However, there is a wide variation in the microbial profile reported from the previous studies; some of which reporting predominance of Gram-positive organisms- streptococcus pneumoniae in particular, while more recent studies reported predominance of Gram-negative organisms, which may indicate a shift in the spectrum of organism colonizing bronchial tree of lung cancer patients in parallel to the increased trends of antibiotic exposures, something this study will re-examine. Moreover, given the paucity of literature highlighting the potential predictors of colonization in such patients, overlooking data on radiological findings in lung cancer patients and underreporting the impact of comorbidities, this study aims to further explore a wider array of potential demographic, clinical, radiological and histological determinants.

Study Timeline

• Study First Submitted: 2023-01-23
• Status Verified: 2023-02
• Study Start: 2023-02-01
• Study First Submitted QC: 2023-02-18
• Study First Posted: 2023-03-01
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-06
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Age > 18 years
• Radiological findings on HRCT chest suggestive of lung cancer (lung mass, pulmonary nodules with , obstructive pneumonia, unexplained lung collapse, mediastinal lymphadenopathy)

Exclusion Criteria

• Patients who demonstrate clinical, laboratory or radiological evidence of active pulmonary infection that requires antibiotic therapy

• Patients in whom histological evidence of lung cancer can't be proven after histopathology

• Patients deemed unfit for bronchoscopy

  • Uncorrected hypoxia under oxygen spo2 <90%
  • Uncontrolled cardiac arrhythmias despite medical treatment and arrhythmias associated with haemodynamic compromise .
  • patient who has risk factors for abnormal coagulation
  • Undrained Pneumothorax
  • Asthma and Chronic obstructive pulmonary disease who had suffered exacerbation during the preceding 3 weeks
  • Myocardial infarction in the previous 4 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of microbial colonization among the study population:	through the study completion , an average of 1 year	Colonization will be defined as isolation of microorganisms from bronchoscopic wash samples at a threshold of 102 cfu.mL-1, whereas infection will be considered at .105 cfu.mL-1 . Regardless of the amount, isolation of mycobacteria and non-commensal fungi will be considered as colonization or an infection depending on the species isolated.
Predictors of microbial colonization among the study population:	through the study completion , an average of 1 year	Demographic, clinical, radiological and histological data will be examined using univariate and multivariate regression analysis to identify their potential predictability of the colonization in patients with lung cancer.

Trial Locations

Locations (1)

Tasneem Hassan Younes; 🇪🇬 Assiut, Egypt