The Role of Narrow Band Imaging (NBI) Bronchoscopy in Detecting Bronchial Squamous Dysplasia in Lung Cancer

NCT06102369 | Enrolling By Invitation DMC

• 1 other identifier: ND-552/UN2.RST/PPM.00.00/2023
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators conducted an observational diagnostic study. The primary objective of the study is to develop a scoring system for detecting pre-lung cancer abnormalities using narrow-band imaging (NBI) bronchoscopy. From the collected data, investigators will perform a multivariate analysis based on the odds ratio (OR) using IBM SPSS software. The result of the data analysis will be transformed into a scoring system aimed to facilitate the early diagnosis of lung cancer, specifically at the pre-cancer stage. This scoring system will also help clinicians detect pre-cancerous abnormalities early and improve patient recovery prospects. Several research questions to be addressed are as follows:

1. 1.What are the NBI image criteria for detecting pre-cancerous lesions in lung tumor patients?
2. 2.What is the diagnostic profile of NBI bronchoscopy in detecting pre-cancerous lesions in lung tumor patients?
3. 3.Can adding the NBI bronchoscopy procedure to the standard bronchoscopy procedure enhance the diagnostic accuracy in detecting pre-cancerous lesions in lung tumor patients?

Conditions

Pulmonary Cancer; Lung Cancer

Keywords

bronchoscopy; narrow-band imaging (NBI); lung cancer; bronchial squamous dysplasia

Outcome Measures

Primary Outcomes (1)

• To determine the sensitivity, specificity, positive predictive value, and negative predictive value of the bronchoscopic narrow-band imaging (NBI) in detecting bronchial squamous dysplasia

  To address this outome, researchers will utilize parameters derived form NBI bronchoscopy images, consist of normal vascularity, increased vascular frequency, dotted, spiral, tortuous and abrupt-ending blood vessels (on a nominal scale). These parameters will be employed in conjunction with histopathological images (dysplasia or non dysplasia) for comparative analysis

  Based on the research timeline, all statistical analysis and data processing will be conducted from January to February 2024

Secondary Outcomes (2)

• To determine the proportion of bronchial squamous dysplasia in lung cancer patients

  Based on the research timeline, all statistical analysis and data processing will be conducted from January to February 2024

• To establish the correlation between the NBI bronchoscopy findings and bronchial squamous dysplasia in lung cancer patients

  Based on the research timeline, all statistical analysis and data processing will be conducted from January to February 2024

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Population: The target population consists of all lung tumor patients. The accessible population consisted of lung tumor patients who underwent bronchoscopy procedures at Persahabatan Hospital from March to December 2023. 2. The study participants: The study participants comprised individuals from the accessible population who met the research subject acceptance criteria and provided informed consent. The consecutive sampling method was employed. 3. The study participants size calculation: The study participants size was calculated using the diagnostic research sample size formula. The minimum study participants size required was 110 subjects.

You may qualify if:

• Patients aged \>18 years undergoing bronchoscopy for diagnostic evaluation of lung tumors.
• Recent radiological examinations, including both chest X-rays and chest CT scans, within the last month, revealed central lesions.

You may not qualify if:

• Refusal to provide informed consent
• Contraindications to bronchoscopy.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Faculty of Medicine

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

formalin-fixed paraffin-embedded (FFPE) tissue

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: March 27, 2023
• Primary Completion: March 31, 2024
• Study Completion: October 30, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)