Pulmonary CancerNCT06102369
The Role of Narrow Band Imaging (NBI) Bronchoscopy in Detecting Bronchial Squamous Dysplasia in Lung Cancer
An observational study of Pulmonary Cancer and Lung Cancer, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Cancer, Lung Cancer
- How many people
- 110 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Mar 2023to 30 Oct 2024
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- Refusal to provide informed consent
- Contraindications to bronchoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- What are the NBI image criteria for detecting pre-cancerous lesions in lung tumor patients?
- What is the diagnostic profile of NBI bronchoscopy in detecting pre-cancerous lesions in lung tumor patients?
- Can adding the NBI bronchoscopy procedure to the standard bronchoscopy procedure enhance the diagnostic accuracy in detecting pre-cancerous lesions in lung tumor patients?
The study population consists of lung tumor patients who have undergone bronchoscopy procedures and meet the protocol acceptance criteria. Bronchial biopsies will be collected from these patients, followed by histopathological examinations.
Read the detailed description
- Study Design: This is an observational diagnostic study. The research was conducted at the Central Surgical Installation (CSI) of Persahabatan Hospital, where bronchoscopy procedures, bronchial biopsy collection, and specimen handling took place. The histopathological examinations were carried out in the Department of Anatomical Pathology, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo National General Hospital. The patient recruitment time ranges from March to December 2023.
- 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.
- 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.
- 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.
- Inclusion criteria:
- Patient aged > 18 years undergoing bronchoscopy for diagnostic evaluation of lung tumors
- Recent radiological examinations, including both chest X-ray and chest CT scans, within the last month, revealed a central lesion of lung cancer
- Exclusion criteria:
- Refusal to provide informed consent
- Contraindications to bronchoscopy
- Study participants selection: Screening was conducted on all lung tumor patients scheduled for bronchoscopy procedures, and the study participants selection was carried out in accordance with the inclusion and exclusion criteria
- Sampling Technique: The preparation and execution of bronchoscopy and bronchial biopsy were performed in accordance with the standard operating procedures (SOP) at Persahabatan Hospital. The bronchoscopy and bronchial biopsy procedures were conducted by a single operator, the principal investigator. The bronchoscopy procedure uses general anesthesia. The flexible fiberoptic bronchoscopy was performed using an Olympus EVIS EXERA III with a Xenon light source, model CLV-190, and BF-1TQ170 series scope. The Boston Scientific Radial JawTM 4 disposable lung biopsy forceps were employed. Bronchoscopy was initially conducted under the white light, followed by narrow-spectrum light. The NBI assessment was performed in two areas, consisting of area 1 (trachea and carina) and area 2 (right main bronchus, right upper lobe orifice, truncus intermedius, right lower lobe orifice, left main bronchus, left upper lobe orifice, and left lower lobe orifice). Biopsies were taken from both areas based on the NBI bronchoscopy findings. Tissue from each area was placed in a separate 10% formalin solution. Tissue processing involved paraffin embedding and Hematoxylin-Eosin staining. Tissue processing was performed using a Tissue Processor machine. Following tissue processing, paraffin blocks were created and sectioned. Hematoxylin-Eosin staining was then performed. Diagnosis of squamous bronchial dysplasia (pre-cancer lesion) was made by a specialist in Anatomical Pathology.
- Data analysis: The research data were recorded on research forms and subsequently entered into SPSS 26 software. the bivariate analysis was conducted between each vascular pattern based on NBI bronchoscopy and the histopathological result. The descriptive data will be presented by the text and tables consist of the basic characteristics of the study participants and research variables. The multivariate analysis was performed on all vascular patterns based on NBI bronchoscopy and histopathological results. Furthermore, a pre-cancer prediction score was generated. An analysis of the AUC (area under the curve) of the squamous dysplasia prediction model form NBI bronchoscopy findings was conducted with a significance level set at p < 0.0.5
- Conditions
- Pulmonary Cancer, Lung Cancer
- Keywords
- bronchoscopy, narrow-band imaging (NBI), lung cancer, bronchial squamous dysplasia
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
This refers to the ratio of the number of cases with squamous bronchial dysplasia to the total number of lung cancer patients in the study. The proportion measures how much squamous bronchial dysplasia is found in lung cancer patients within the study population (descriptive analysis)
Measured: 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
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). Additionally, bivariate analysis followed by multivariate logistic regression analysis is conducted between the NBI bronchoscopy image and squamous bronchial dysplasia.
Measured: Based on the research timeline, all statistical analysis and data processing will be conducted from January to February 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start27 Mar 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary CancerStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 only
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mia Elhidsi, MD, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102369
- Sponsor's protocol ID
- ND-552/UN2.RST/PPM.00.00/2023
- Status last verified
- Mar 2024
- First submitted
- 22 Oct 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers might be engaging in consultations with ethics boards, legal experts, and stakeholders to develop a robust and ethical sharing plan that adheres to the highest standards of privacy and security.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Narrow Band Imaging (NBI) Bronchoscopy in Detecting Bronchial Squamous Dysplasia in Lung Cancer
- ClinicalTrials.gov ID
- NCT06102369
- Acronym / sponsor ID
- ND-552/UN2.RST/PPM.00.00/2023
- Conditions
- Pulmonary Cancer, Lung Cancer
- Keywords
- bronchoscopy, narrow-band imaging (NBI), lung cancer, bronchial squamous dysplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the NBI image criteria for detecting pre-cancerous lesions in lung tumor patients?
- What is the diagnostic profile of NBI bronchoscopy in detecting pre-cancerous lesions in lung tumor patients?
- Can adding the NBI bronchoscopy procedure to the standard bronchoscopy procedure enhance the diagnostic accuracy in detecting pre-cancerous lesions in lung tumor patients?
The study population consists of lung tumor patients who have undergone bronchoscopy procedures and meet the protocol acceptance criteria. Bronchial biopsies will be collected from these patients, followed by histopathological examinations.
Detailed description
- Study Design: This is an observational diagnostic study. The research was conducted at the Central Surgical Installation (CSI) of Persahabatan Hospital, where bronchoscopy procedures, bronchial biopsy collection, and specimen handling took place. The histopathological examinations were carried out in the Department of Anatomical Pathology, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo National General Hospital. The patient recruitment time ranges from March to December 2023.
- 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.
- 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.
- 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.
- Inclusion criteria:
- Patient aged > 18 years undergoing bronchoscopy for diagnostic evaluation of lung tumors
- Recent radiological examinations, including both chest X-ray and chest CT scans, within the last month, revealed a central lesion of lung cancer
- Exclusion criteria:
- Refusal to provide informed consent
- Contraindications to bronchoscopy
- Study participants selection: Screening was conducted on all lung tumor patients scheduled for bronchoscopy procedures, and the study participants selection was carried out in accordance with the inclusion and exclusion criteria
- Sampling Technique: The preparation and execution of bronchoscopy and bronchial biopsy were performed in accordance with the standard operating procedures (SOP) at Persahabatan Hospital. The bronchoscopy and bronchial biopsy procedures were conducted by a single operator, the principal investigator. The bronchoscopy procedure uses general anesthesia. The flexible fiberoptic bronchoscopy was performed using an Olympus EVIS EXERA III with a Xenon light source, model CLV-190, and BF-1TQ170 series scope. The Boston Scientific Radial JawTM 4 disposable lung biopsy forceps were employed. Bronchoscopy was initially conducted under the white light, followed by narrow-spectrum light. The NBI assessment was performed in two areas, consisting of area 1 (trachea and carina) and area 2 (right main bronchus, right upper lobe orifice, truncus intermedius, right lower lobe orifice, left main bronchus, left upper lobe orifice, and left lower lobe orifice). Biopsies were taken from both areas based on the NBI bronchoscopy findings. Tissue from each area was placed in a separate 10% formalin solution. Tissue processing involved paraffin embedding and Hematoxylin-Eosin staining. Tissue processing was performed using a Tissue Processor machine. Following tissue processing, paraffin blocks were created and sectioned. Hematoxylin-Eosin staining was then performed. Diagnosis of squamous bronchial dysplasia (pre-cancer lesion) was made by a specialist in Anatomical Pathology.
- Data analysis: The research data were recorded on research forms and subsequently entered into SPSS 26 software. the bivariate analysis was conducted between each vascular pattern based on NBI bronchoscopy and the histopathological result. The descriptive data will be presented by the text and tables consist of the basic characteristics of the study participants and research variables. The multivariate analysis was performed on all vascular patterns based on NBI bronchoscopy and histopathological results. Furthermore, a pre-cancer prediction score was generated. An analysis of the AUC (area under the curve) of the squamous dysplasia prediction model form NBI bronchoscopy findings was conducted with a significance level set at p < 0.0.5
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusal to provide informed consent
- Contraindications to bronchoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the sensitivity, specificity, positive predictive value, and negative predictive value of the bronchoscopic narrow-band imaging (NBI) in detecting bronchial squamous dysplasia
Time frame: Based on the research timeline, all statistical analysis and data processing will be conducted from January to February 2024
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
2 secondary outcomes
To determine the proportion of bronchial squamous dysplasia in lung cancer patients
Time frame: 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
Time frame: Based on the research timeline, all statistical analysis and data processing will be conducted from January to February 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No. Researchers might be engaging in consultations with ethics boards, legal experts, and stakeholders to develop a robust and ethical sharing plan that adheres to the highest standards of privacy and security.
Related trials for Pulmonary Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Cancer and Lung Cancer, run by Universitas Indonesia at 1 site in Indonesia.
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 2 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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 Indonesia. 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?
Results are not available in the source record.
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?
To determine the sensitivity, specificity, positive predictive value, and negative predictive value of the bronchoscopic narrow-band imaging (NBI) in detecting bronchial squamous dysplasia (time frame: Based on the research timeline, all statistical analysis and data processing will be conducted from January to February 2024). 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 6 Mar 2024.