Lung CancerNCT05992740
Role of Bronchoscope in Diagnosis of Lung Cancer
A study testing bronchoscope in people with Lung Cancer, run by Assiut University.
Trial summary
The study aims to compare the diagnostic yields of bronchial brushing performed before and after forceps biopsy and bronchial wash performed before and after biopsy during flexible bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- bronchoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to Oct 2025
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in whom clinical findings, radiological examination suggested lung malignancy. patients with chronic cough, hemoptysis and lymph node enlargement.
Who cannot join
- patients with no evidence of malignancy.
Trial locations and contacts
No sites are listed yet.
manal ahmed contact
About this study
Official title: The Optimal Sequence of Bronchial Brushing, Forceps Biopsy and Washing for Diagnosis of Lung Cancer
The study aims to compare the diagnostic yields of bronchial brushing performed before and after forceps biopsy and bronchial wash performed before and after biopsy during flexible bronchoscopy.
Read the detailed description
Lung cancer is the most common cause of cancer-related mortality in both sexes in the world. To treat the disease successfully, it should be diagnosed at the earliest possible stage. Several studies have demonstrated that early detection, localization, and aggressive treatment of lung cancer result in the 5-year survival rate of 70-80%. Nowadays, bronchoscopy is an invaluable tool for diagnosis of lung cancer and various diagnostic tools have been developed using flexible fiber-optic bronchoscopy (FOB).
Bronchoscopy, while essential for diagnosing and staging lung cancer, can give variable diagnostic yields ranging from37-77%. One reason for this variability is limitations in tissue sampling techniques, which can make it impossible to obtain the most representative area of neoplastic tissue. Numerous basic diagnostic procedures using FB, including bronchoalveolar lavage or washing, brushing, endobronchial or transbronchial biopsy(TBB), and transbronchial needle aspiration, have been evaluated in various combinations to improve the diagnostic yield of FB in patients with suspected lung cancer. However, the optimum sequence of brushing, washing and biopsy samples for diagnosing peripheral lung cancer is not clear and requires further study.
- Conditions
- Lung Cancer
- Being tested
- bronchoscope
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopeDevice
bronchoscpe with broncial brush and biopsy or bronchial wash and biopsy
| Study group | Role | What they receive |
|---|---|---|
| bronchial wash group | Active comparator | the patients will undergo bronchoscope then pre-biopsy bronchial wash, biopsy, post-biopsy bronchial wash will be obtained Receives: Device: bronchoscope |
| bronchial brush | Active comparator | the patients will undergo bronchoscope then pre-biopsy bronchial brush, biopsy, post-biopsy bronchial brush will be obtained Receives: Device: bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between diagnostic yields of different tissue sampling techniques of bronchoscope in lung cancer diagnosis
we will compare between the diagnostic yield of bronchial brushing group (pre-biopsy brushing + forceps biopsy + post-biopsy brushing) with the diagnostic yield of bronchial wash group (pre-biopsy bronchial wash + biopsy + post-biopsy bronchial wash).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- analytical cross sectional
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Maged Monir, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992740
- Sponsor's protocol ID
- bronchoscope in lung cancer
- Status last verified
- Sep 2023
- First submitted
- 8 Aug 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hou G, Miao Y, Hu XJ, Wang W, Wang QY, Wu GP, Wang EH, Kang J. The optimal sequence for bronchial brushing and forceps biopsy in lung cancer diagnosis: a random control study. J Thorac Dis. 2016 Mar;8(3):520-6. doi: 10.21037/jtd.2016.02.12.
PubMed 27076949Lim JH, Kim MJ, Jeon SH, Park MH, Kim WY, Lee M, Kim JH, Kim JS, Kim YS, Kim L, Lee KH, Kwak SM, Shin H, Nam HS. The optimal sequence of bronchial brushing and washing for diagnosing peripheral lung cancer using non-guided flexible bronchoscopy. Sci Rep. 2020 Jan 23;10(1):1036. doi: 10.1038/s41598-020-58010-w.
PubMed 31974454
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Sequence of Bronchial Brushing, Forceps Biopsy and Washing for Diagnosis of Lung Cancer
- ClinicalTrials.gov ID
- NCT05992740
- Acronym / sponsor ID
- bronchoscope in lung cancer
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 15 Aug 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.
The study aims to compare the diagnostic yields of bronchial brushing performed before and after forceps biopsy and bronchial wash performed before and after biopsy during flexible bronchoscopy.
Detailed description
Lung cancer is the most common cause of cancer-related mortality in both sexes in the world. To treat the disease successfully, it should be diagnosed at the earliest possible stage. Several studies have demonstrated that early detection, localization, and aggressive treatment of lung cancer result in the 5-year survival rate of 70-80%. Nowadays, bronchoscopy is an invaluable tool for diagnosis of lung cancer and various diagnostic tools have been developed using flexible fiber-optic bronchoscopy (FOB).
Bronchoscopy, while essential for diagnosing and staging lung cancer, can give variable diagnostic yields ranging from37-77%. One reason for this variability is limitations in tissue sampling techniques, which can make it impossible to obtain the most representative area of neoplastic tissue. Numerous basic diagnostic procedures using FB, including bronchoalveolar lavage or washing, brushing, endobronchial or transbronchial biopsy(TBB), and transbronchial needle aspiration, have been evaluated in various combinations to improve the diagnostic yield of FB in patients with suspected lung cancer. However, the optimum sequence of brushing, washing and biopsy samples for diagnosing peripheral lung cancer is not clear and requires further study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- analytical cross sectional
| Arm | Type | Receives |
|---|---|---|
| bronchial wash group | Active comparator | Device: bronchoscopethe patients will undergo bronchoscope then pre-biopsy bronchial wash, biopsy, post-biopsy bronchial wash will be obtained |
| bronchial brush | Active comparator | Device: bronchoscopethe patients will undergo bronchoscope then pre-biopsy bronchial brush, biopsy, post-biopsy bronchial brush will be obtained |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in whom clinical findings, radiological examination suggested lung malignancy. patients with chronic cough, hemoptysis and lymph node enlargement.
Key exclusion criteria (1 listed)
- patients with no evidence of malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchoscopebronchoscpe with broncial brush and biopsy or bronchial wash and biopsy | Device | bronchial brush, bronchial wash group |
Primary outcome
comparison between diagnostic yields of different tissue sampling techniques of bronchoscope in lung cancer diagnosis
Time frame: 2 years
we will compare between the diagnostic yield of bronchial brushing group (pre-biopsy brushing + forceps biopsy + post-biopsy brushing) with the diagnostic yield of bronchial wash group (pre-biopsy bronchial wash + biopsy + post-biopsy bronchial wash).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Background: PubMed 27076949Hou G, Miao Y, Hu XJ, Wang W, Wang QY, Wu GP, Wang EH, Kang J. The optimal sequence for bronchial brushing and forceps biopsy in lung cancer diagnosis: a random control study. J Thorac Dis. 2016 Mar;8(3):520-6. doi: 10.21037/jtd.2016.02.12.
- Background: PubMed 31974454Lim JH, Kim MJ, Jeon SH, Park MH, Kim WY, Lee M, Kim JH, Kim JS, Kim YS, Kim L, Lee KH, Kwak SM, Shin H, Nam HS. The optimal sequence of bronchial brushing and washing for diagnosing peripheral lung cancer using non-guided flexible bronchoscopy. Sci Rep. 2020 Jan 23;10(1):1036. doi: 10.1038/s41598-020-58010-w.
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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.
manal ahmed contact
Questions about this trial
What is this clinical trial studying?
A study testing bronchoscope in people with Lung Cancer, run by Assiut University.
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 1 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 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact merna maged (+201284143158, mernamaged1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between diagnostic yields of different tissue sampling techniques of bronchoscope in lung cancer diagnosis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05992740, which also lists 2 linked publications.
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 14 Sep 2023.