Microbial Colonization in Lung Cancer Patients

March 2, 2023 updated by: Tasneem Hassan Younes, Assiut University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 29601288800041
        • Recruiting
        • Tasneem Hassan Younes
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hebatallah G Rashed, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of microbial colonization among the study population:
Time Frame: 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.
through the study completion , an average of 1 year
Predictors of microbial colonization among the study population:
Time Frame: 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.
through the study completion , an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohamed M Abdelhadi, professor, Assiut University
  • Principal Investigator: Hebatallah G Rashed, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

February 18, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Microbial colonization

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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