Clinical trial NCT05748795: Microbial Colonization in Lung Cancer Patients
Official title: Microbial Colonization in Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbial Colonization
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted on patients who are undergoing flexible bronchoscopy for diagnosis of Lung cancer. A written consent will be obtained from all participants prior to the procedure.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of microbial colonization among the study population:
timeFrame: through the study completion , an average of 1 year
measure: Predictors of microbial colonization among the study population:
timeFrame: through the study completion , an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Tasneem Hassan Younes
Study officials:
affiliation: Assiut University
name: Mohamed M Abdelhadi, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Hebatallah G Rashed, professor
role: PRINCIPAL_INVESTIGATOR
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