Lung CancerNCT05799027
Raman Spectroscopic Analysis of Bronchoscopic Biopsy for Diagnosing Lung Cancer
A study testing Raman spectrum in people with Lung Cancer, run by China-Japan Friendship Hospital.
Trial summary
The goal of this clinical trial is to evaluate raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer in visible lesions in the airway. The main question it aims to answer are: the diagnostic efficacy raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer. 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?
- Raman spectrum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2023to 31 Dec 2024
- 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 who plan to undergo bronchoscopic biopsy or EBUS-TBNA
- Visible intratracheal lesions under bronchoscope
- Non-visible lesions suspected of lung cancer
Who cannot join
- The patient could not tolerate further examination aimed at clarifying the cause of the disease or refused to accept further examination aimed at clarifying the cause of the disease due to poor general condition, serious organ dysfunction, etc
- The patient has no definite diagnosis
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this clinical trial is to evaluate raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer in visible lesions in the airway. The main question it aims to answer are: the diagnostic efficacy raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer.
The bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis.
- Conditions
- Lung Cancer
- Being tested
- Raman spectrum
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raman spectrumDiagnostic test
The bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis.
| Study group | Role | What they receive |
|---|---|---|
| Raman spectrum analysis | Experimental | The bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis. Receives: Diagnostic Test: Raman spectrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the sensitivities and specificities of Raman spectroscopic analysis of bronchoscopic biopsy for lung cancer.
The diagnosis would be confirmed according to the pathological results.
Measured: 7 days after the biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start31 Mar 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799027
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-01-0201-05
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raman Spectroscopic Analysis of Bronchoscopic Biopsy for Diagnosing Lung Cancer
- ClinicalTrials.gov ID
- NCT05799027
- Acronym / sponsor ID
- 2022-NHLHCRF-LX-01-0201-05
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 31 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Apr 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 goal of this clinical trial is to evaluate raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer in visible lesions in the airway. The main question it aims to answer are: the diagnostic efficacy raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer.
The bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raman spectrum analysis | Experimental | Diagnostic Test: Raman spectrumThe bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who plan to undergo bronchoscopic biopsy or EBUS-TBNA
- Visible intratracheal lesions under bronchoscope
- Non-visible lesions suspected of lung cancer
Key exclusion criteria (2 listed)
- The patient could not tolerate further examination aimed at clarifying the cause of the disease or refused to accept further examination aimed at clarifying the cause of the disease due to poor general condition, serious organ dysfunction, etc
- The patient has no definite diagnosis
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 |
|---|---|---|
| Raman spectrumThe bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis. | Diagnostic test | Raman spectrum analysis |
Primary outcome
To establish the sensitivities and specificities of Raman spectroscopic analysis of bronchoscopic biopsy for lung cancer.
Time frame: 7 days after the biopsy
The diagnosis would be confirmed according to the pathological results.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Raman spectrum in people with Lung Cancer, run by China-Japan Friendship Hospital.
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 3 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 5 Apr 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 Mingming Deng, MD (86 18801336854, isdeng1017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the sensitivities and specificities of Raman spectroscopic analysis of bronchoscopic biopsy for lung cancer. (time frame: 7 days after the biopsy). 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 5 Apr 2023.