Lung NeoplasmsNCT02277366
Role of Bronchoscopy in Early Lung Cancer Screening of High Risk Population
An observational study of Lung Neoplasms, run by Tang-Du Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the diagnostic yield of early lung cancer in high risk population, who smokes or has other risk factors, by different bronchoscopy,. Furthermore, another purpose is to determine whether the different bronchoscopy are significant different in diagnosing early lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Fluorescence Bronchoscopy/Narrow Band Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Nov 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients recruited in the study should meet one item as follows. * Patient is over 40 years in age and is a heavy cigarette smoker.(smoking index is over 400.) * Patient has been coughing irritably for 2-3 weeks with a failed treatment and without obvious causes. * The nature of cough changes in a patient who has chronic respiratory disease. * Patient has blood-stained sputum persistently or repeatedly without obvious causes.
Who may be able to join
- Patient is over 40 years in age and is a heavy cigarette smoker.(smoking index is over 400)
- Patient has been coughing irritably for 2-3 weeks with a failed treatment and without obvious causes.
- The nature of cough changes in a patient who has chronic respiratory disease.
- Patient has blood-stained sputum persistently or repeatedly without obvious causes.
- Patient will be included if accorded with any item of above.
Who cannot join
- Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
- Patient has uncontrollable hypertension (SBP > 180mmHg).
- Patient has severe organ dysfunction (shock, severe hepatic and renal dysfunction, massive hemorrhage of upper gastrointestine, diffuse intravascular coagulation(DIC) and massive hemoptysis,etc).
- Patient has blood coagulation disorders (PT>2 times the upper limit of normal(ULN) or Platelet(PLT)<50000/ul）.
- Patient has severe dyspnea.
- Patient is allergic to local anesthetic.
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- Patient is unable to provide informed consent.
- Patient is not an appropriate candidate for or is unable to tolerate flexible bronchoscopy procedures.
- Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints.
- Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
- Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study.
- Patient has pulmonary lesions suspected to be cancer from CT images.
- Female patient of childbearing potential has a positive result from a pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center Randomized Control Study of Bronchoscopy in Early Lung Cancer Screening of High Risk Population
The purpose of this study is to determine the diagnostic yield of early lung cancer in high risk population, who smokes or has other risk factors, by different bronchoscopy,. Furthermore, another purpose is to determine whether the different bronchoscopy are significant different in diagnosing early lung cancer.
- Conditions
- Lung Neoplasms
- Being tested
- Fluorescence Bronchoscopy/Narrow Band Bronchoscopy
- Keywords
- Lung Neoplasms, Bronchoscopy, Early Detection of Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence Bronchoscopy/Narrow Band BronchoscopyProcedure or surgery
Fluorescence Bronchoscopy and Narrow Band Bronchoscopy are used in the Fluorescence/Narrow Band Bronchoscopy group to make a diagnosis of lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence/Narrow Band Bronchoscopy | All patients in the group are examined by Fluorescence Bronchoscopy and Narrow Band Bronchoscopy to make a early detection of lung cancer. Receives: Procedure: Fluorescence Bronchoscopy/Narrow Band Bronchoscopy | |
| Routine Bronchoscopy | All patients in this group are examined by routine bronchoscopy to make a early detection of lung cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of Lung Cancer
Measured: 1 week
Secondary outcomes (1)
Number of Participants with Serious Adverse Events
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startMay 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: We have recruited some patients, but we haven't found any significant result by bronchoscopy in the high risk population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Tang-Du 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing, China Meitan General Hospital, MICRO-TECH (Nanjing) Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Faguang Jin, Ph.D, MD, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277366
- Sponsor's protocol ID
- lungcancer screening
- Other IDs
- 201402024-BS
- Status last verified
- Nov 2015
- First submitted
- 21 Oct 2014
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moghissi K, Dixon K, Stringer MR. Current indications and future perspective of fluorescence bronchoscopy: a review study. Photodiagnosis Photodyn Ther. 2008 Dec;5(4):238-46. doi: 10.1016/j.pdpdt.2009.01.008. Epub 2009 Feb 23.
PubMed 19356663Ali AH, Takizawa H, Kondo K, Nakagawa Y, Toba H, Khasag N, Kenzaki K, Sakiyama S, Mohammadien HA, Mokhtar EA, Tangoku A. Follow-up using fluorescence bronchoscopy for the patients with photodynamic therapy treated early lung cancer. J Med Invest. 2011 Feb;58(1-2):46-55. doi: 10.2152/jmi.58.46.
PubMed 21372486Edell E, Lam S, Pass H, Miller YE, Sutedja T, Kennedy T, Loewen G, Keith RL, Gazdar A. Detection and localization of intraepithelial neoplasia and invasive carcinoma using fluorescence-reflectance bronchoscopy: an international, multicenter clinical trial. J Thorac Oncol. 2009 Jan;4(1):49-54. doi: 10.1097/JTO.0b013e3181914506.
PubMed 19096306Venmans BJ, Van Boxem TJ, Smit EF, Postmus PE, Sutedja TG. Results of two years expenience with fluorescence bronchoscopy in detection of preinvasive bronchial neoplasia. Diagn Ther Endosc. 1999;5(2):77-84. doi: 10.1155/DTE.5.77.
PubMed 18493485Gabrecht T, Lovisa B, van den Bergh H, Wagnieres G. Autofluorescence bronchoscopy: quantification of inter-patient variations of fluorescence intensity. Lasers Med Sci. 2009 Jan;24(1):45-51. doi: 10.1007/s10103-007-0518-y. Epub 2007 Nov 30.
PubMed 18060444
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Control Study of Bronchoscopy in Early Lung Cancer Screening of High Risk Population
- ClinicalTrials.gov ID
- NCT02277366
- Acronym / sponsor ID
- lungcancer screening
- Conditions
- Lung Neoplasms
- Keywords
- Lung Neoplasms, Bronchoscopy, Early Detection of Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We have recruited some patients, but we haven't found any significant result by bronchoscopy in the high risk population.
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Xinqiao Hospital of Chongqing, China Meitan General Hospital, MICRO-TECH (Nanjing) Co., Ltd
- Study start
- May 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 29 Oct 2014 (estimated)
- 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 purpose of this study is to determine the diagnostic yield of early lung cancer in high risk population, who smokes or has other risk factors, by different bronchoscopy,. Furthermore, another purpose is to determine whether the different bronchoscopy are significant different in diagnosing early lung cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluorescence/Narrow Band Bronchoscopy | – | Procedure: Fluorescence Bronchoscopy/Narrow Band BronchoscopyAll patients in the group are examined by Fluorescence Bronchoscopy and Narrow Band Bronchoscopy to make a early detection of lung cancer. |
| Routine Bronchoscopy | – | –All patients in this group are examined by routine bronchoscopy to make a early detection of lung cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients recruited in the study should meet one item as follows. * Patient is over 40 years in age and is a heavy cigarette smoker.(smoking index is over 400.) * Patient has been coughing irritably for 2-3 weeks with a failed treatment and without obvious causes. * The nature of cough changes in a patient who has chronic respiratory disease. * Patient has blood-stained sputum persistently or repeatedly without obvious causes.
Key inclusion criteria (5 listed)
- Patient is over 40 years in age and is a heavy cigarette smoker.(smoking index is over 400)
- Patient has been coughing irritably for 2-3 weeks with a failed treatment and without obvious causes.
- The nature of cough changes in a patient who has chronic respiratory disease.
- Patient has blood-stained sputum persistently or repeatedly without obvious causes.
- Patient will be included if accorded with any item of above.
Key exclusion criteria (13 listed)
- Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
- Patient has uncontrollable hypertension (SBP > 180mmHg).
- Patient has severe organ dysfunction (shock, severe hepatic and renal dysfunction, massive hemorrhage of upper gastrointestine, diffuse intravascular coagulation(DIC) and massive hemoptysis,etc).
- Patient has blood coagulation disorders (PT>2 times the upper limit of normal(ULN) or Platelet(PLT)<50000/ul）.
- Patient has severe dyspnea.
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 |
|---|---|---|
| Fluorescence Bronchoscopy/Narrow Band BronchoscopyFluorescence Bronchoscopy and Narrow Band Bronchoscopy are used in the Fluorescence/Narrow Band Bronchoscopy group to make a diagnosis of lung cancer. | Procedure or surgery | Fluorescence/Narrow Band Bronchoscopy |
Primary outcome
Diagnostic yield of Lung Cancer
Time frame: 1 week
1 secondary outcome
Number of Participants with Serious Adverse Events
Time frame: 1 week
Results and safety
The study was stopped early (reason given: We have recruited some patients, but we haven't found any significant result by bronchoscopy in the high risk population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
- Background: PubMed 19356663Moghissi K, Dixon K, Stringer MR. Current indications and future perspective of fluorescence bronchoscopy: a review study. Photodiagnosis Photodyn Ther. 2008 Dec;5(4):238-46. doi: 10.1016/j.pdpdt.2009.01.008. Epub 2009 Feb 23.
- Background: PubMed 21372486Ali AH, Takizawa H, Kondo K, Nakagawa Y, Toba H, Khasag N, Kenzaki K, Sakiyama S, Mohammadien HA, Mokhtar EA, Tangoku A. Follow-up using fluorescence bronchoscopy for the patients with photodynamic therapy treated early lung cancer. J Med Invest. 2011 Feb;58(1-2):46-55. doi: 10.2152/jmi.58.46.
- Background: PubMed 19096306Edell E, Lam S, Pass H, Miller YE, Sutedja T, Kennedy T, Loewen G, Keith RL, Gazdar A. Detection and localization of intraepithelial neoplasia and invasive carcinoma using fluorescence-reflectance bronchoscopy: an international, multicenter clinical trial. J Thorac Oncol. 2009 Jan;4(1):49-54. doi: 10.1097/JTO.0b013e3181914506.
- Background: PubMed 18493485Venmans BJ, Van Boxem TJ, Smit EF, Postmus PE, Sutedja TG. Results of two years expenience with fluorescence bronchoscopy in detection of preinvasive bronchial neoplasia. Diagn Ther Endosc. 1999;5(2):77-84. doi: 10.1155/DTE.5.77.
- Background: PubMed 18060444Gabrecht T, Lovisa B, van den Bergh H, Wagnieres G. Autofluorescence bronchoscopy: quantification of inter-patient variations of fluorescence intensity. Lasers Med Sci. 2009 Jan;24(1):45-51. doi: 10.1007/s10103-007-0518-y. Epub 2007 Nov 30.
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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.
Faguang Jin, Ph.D, MD principal investigator
Tang-Du Hospital
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 Lung Neoplasms, run by Tang-Du Hospital at 1 site in China.
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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 16 Nov 2015. 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 China. 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 was stopped early (reason given: We have recruited some patients, but we haven't found any significant result by bronchoscopy in the high risk population.). 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?
Diagnostic yield of Lung Cancer (time frame: 1 week). 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 NCT02277366, which also lists 5 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 16 Nov 2015.