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Lung CancerNCT05575388

Pattern of Isolated Fungi From Bronchoalveolar Lavage Among Patients With Lung Cancer

An observational study of Lung Cancer, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to assess the prevalence and pattern of isolated fungi from patients with lung cancer at the time of diagnosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Mar 2018to 1 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients definitely diagnosed as central bronchogenic carcinoma

Who may be able to join

  • All patients definitely diagnosed as central bronchogenic carcinoma from positive cytopathology of specimens taken through investigation by FOB before receiving any specific treatment.

Who cannot join

  • the presence of neutropenia with an absolute neutrophil count < 1,000/µL (equivalent to < 1.0 × 109/L)
  • patients on systemic corticosteroids therapy or those on chemotherapy or radiotherapy or antifungal treatment

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Medicine

    Al Mansurah, 35516

Other trials in Egypt

About this study

Official title: Pattern of Isolated Fungi From Bronchoalveolar Lavage Among Patients With Lung Cancer, a Prospective Cross Sectional Study.

The aim of the study is to assess the prevalence and pattern of isolated fungi from patients with lung cancer at the time of diagnosis.

Read the detailed description

The role of infection as a cause of lung cancer is still being debated. Also, identification of potentially pathogenic organisms colonizing the lower respiratory tract in patients with lung cancer is important as this may increase the risk of lung infections in the natural course of lung cancer that can restrain the effect of oncological treatment and affect their survival (Klastersky and Aoun, 2004). Screening those cases for fungal colonization of the respiratory tract would characterize patients who needed closer monitoring for the occurrence of potential complications such as acute invasive fungal infection (Biswas et al., 2010).

Aim of the study The aim of the study is to detect the prevalence and pattern of isolated fungi from patients with lung cancer at the time of diagnosis before starting chemotherapy or radiotherapy.

Patients:

Inclusion criteria:

Patients presented to chest medicine department outpatient clinic with radiological and/or clinical manifestations suspicious of lung cancer such as a hilar mass, collapse or unresolved consolidation with accompanying volume loss according to Hollings and Shawn, (2000), will be subjected to FOB for diagnosis. Those definitely diagnosed as central bronchogenic carcinoma will be included in the study.

Exclusion criteria:

  • Patients with active tuberculosis.
  • Patients with HIV (human immunodeficiency virus) infection.
  • Presence of neutropenia defined as an absolute neutrophil count (ANC) < 1,000/µL (equivalent to < 1.0 × 109/L) according to Taplitz et al., (2018).
  • Patients on systemic corticosteroids therapy.
  • Patients on chemotherapy or radiotherapy.
  • Patients on antifungal therapy.
  • Patients with absolute contraindications to FOB including who were hemodynamically unstable or with platelet counts could not be maintained over 50 × 109 /l or INR > 1.5 and patients with refractory hypoxemia.

Study design:

This is cross-sectional prospective study

Methods:

All patients will be subjected to the following:

  1. Demographic data (age and sex), smoking history and co-morbid diseases as COPD, hypertension (HTN), diabetes mellitus (DM), ischemic heart disease, bronchial asthma (BA) and previous malignancy.
  2. Full history taking with stress on dyspnea, cough, chest pain, hemoptysis, toxemic symptoms and compressive manifestations.
  3. Dyspnea score was evaluated according to The MRC breathlessness scale (2008).
  4. Hemoptysis score was evaluated according to the amount of blood expectorated in 24 h into as mild (< 30 ml), moderate (31-100 ml), severe (100-600 ml) and massive (> 600 mL) according to Ozgül et al., (2005).
  5. Cough score assessment from 0 to 5 according to Hsu et al., (1994).
  6. Chest pain scoring was done according to The McGill Pain Questionnaire (Melzack, 1987).
  7. General and local chest examination.
  8. Laboratory work up:
  9. Complete blood count(CBC).
  10. Liver function tests.
  11. Serum creatinine.
  12. Coagulation profile (prothrombin time, INR, APTT and platelet count).
  13. Virology profile (HBV, HCV and HIV).
  14. Radiological assessment (Chest X-ray and CT chest):
  15. Description either nodule, mass, cavity, consolidation or ground glass opacity according to Hollings and Shawn, (2000).
  16. Evaluation of the tumor size ,site of and its effect on lobar or total lung collapse.
  17. Hilar and mediastinal lymphadenopathy assessment according to El-Sherief et al., (2004).
  18. Presence of pleural effusion.
  19. Chest wall invasion.

Bronchoscopic procedures FOB examination will be performed using the video-bronchoscopes (PENTAX EB 1575 K) manufactured by Pentax Company Tokyo, Japan.

Bronchoscopic findings will be interpretated into:

  1. Visible tumors may be either:
  2. Tumor protruding from the bronchial wall into the bronchial lumen.
  3. Nodular mucosa without definitive mass.
  4. Bronchial wall distortion: the mucosa appears normal but there are secondary effects produced by tumor such as compression, edema or stenosis.
  5. No abnormality detected.

Preservation of samples:

  1. The BAL fluid will be collected in two sterile containers and transported immediately, one sample to the mycology laboratory and the other to cytological lab.
  2. Tissue samples will be divided into 2 parts:
  3. Part (A) will be put in saline containing tube that will be transferred to the microbiology laboratory for staining for fungi and fungus culture.
  4. Part (B) will be preserved in formalin 10% for histopathological examination of the tumor, cell typing with Hematoxylin and Eosin and immunostaining when needed as well as staining for fungi in lung tumor biopsies with silver stain .

Diagnostic criteria for fungal infection will be considered according to De Pauw et al., (2008):

Proven" fungal infection : positive fungal culture or histological demonstration of fungal or hyphal elements in a specimen of the diseased tissue excluding bronchoalveolar lavage.

Fungus colonization : positive fungal culture in patients who do not meet the above criteria for proven .

Conditions
Lung Cancer
Keywords
lung cancer, fungal colonization, fiberoptic bronchoscopy
Medical subject headings
Lung Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of participants with positive fungal growth

    assessed by fungal culture of BAL

    Measured: April 2018 and October 2020

Secondary outcomes (1)
  1. predictors of fungal infection in lung cancer participants

    assessed by comparing lung cancer cases with fungal infection vs those with negative fungal growth as regards characteristics of the participants and cell types of lung cancer

    Measured: April 2018 and October 2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2022
  2. Study start1 Mar 2018
  3. Primary completion1 Oct 2020
  4. Study completion1 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05575388
Sponsor's protocol ID
MS/353
Status last verified
Oct 2022
First submitted
6 Oct 2022
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of participants with positive fungal growth (time frame: April 2018 and October 2020). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

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