Lung CancerNCT01623765
Lung Cancer Diagnosis and Staging Using Ultrasound Guidance
An observational study of Lung Cancer, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
To collect data of all patients who have undergone Endobronchial ultrasound for diagnosis or staging of suspected lung cancer Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Lung Cancer
- How many people
- 680 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2010to Jul 2014
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected lung cancer
Who may be able to join
- Patients who have undergone endobronchial ultrasound
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosis and Staging of Lung Cancer Using Minimally Invasive Technique With Ultrasound Guidance
To collect data of all patients who have undergone Endobronchial ultrasound for diagnosis or staging of suspected lung cancer
Read the detailed description
Introduction: Endobronchial Ultrasound (EBUS) is a procedure that is performed via flexible bronchoscopy under moderate sedation for visualization of lymph nodes in the chest and biopsy under real-time guidance for the staging of lung cancer or evaluation of enlarged lymph nodes. In addition, lung lesions or masses can be visualized and biopsied in the same sitting. The use of EBUS has enhanced the safety and diagnostic yield of flexible bronchoscopy.
Aim: The data of patients with suspected lung cancer or undiagnosed lymph node enlargement in whom bronchoscopy with EBUS guidance is clinically indicated will be collected prospectively.
Results from EBUS are considered positive if a specific diagnosis is obtained ( eg malignancy) or if lymphocytes are present in the lymph node biopsy, indicating accurate sampling of lymph node. In patients with non-diagnostic EBUS, the results from other procedures will be compared for analysis.
- Conditions
- Lung Cancer
- Keywords
- Endobronchial ultrasound, lung cancer
- Medical subject headings
- Lung Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJan 2010
- Primary completionJul 2014
- Study completionJul 2014
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 Singapore General 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 only
- Time perspective
- Prospective
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623765
- Sponsor's protocol ID
- 2008/458/B
- Status last verified
- Sep 2019
- First submitted
- 18 Jun 2012
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Staging of Lung Cancer Using Minimally Invasive Technique With Ultrasound Guidance
- ClinicalTrials.gov ID
- NCT01623765
- Acronym / sponsor ID
- 2008/458/B
- Conditions
- Lung Cancer
- Keywords
- Endobronchial ultrasound, lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Jun 2012 (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.
To collect data of all patients who have undergone Endobronchial ultrasound for diagnosis or staging of suspected lung cancer
Detailed description
Introduction: Endobronchial Ultrasound (EBUS) is a procedure that is performed via flexible bronchoscopy under moderate sedation for visualization of lymph nodes in the chest and biopsy under real-time guidance for the staging of lung cancer or evaluation of enlarged lymph nodes. In addition, lung lesions or masses can be visualized and biopsied in the same sitting. The use of EBUS has enhanced the safety and diagnostic yield of flexible bronchoscopy.
Aim: The data of patients with suspected lung cancer or undiagnosed lymph node enlargement in whom bronchoscopy with EBUS guidance is clinically indicated will be collected prospectively.
Results from EBUS are considered positive if a specific diagnosis is obtained ( eg malignancy) or if lymphocytes are present in the lymph node biopsy, indicating accurate sampling of lymph node. In patients with non-diagnostic EBUS, the results from other procedures will be compared for analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected lung cancer
Key inclusion criteria (1 listed)
- Patients who have undergone endobronchial ultrasound
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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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.
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 Lung Cancer, run by Singapore General Hospital at 1 site in Singapore.
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 0 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: finished, as of the sponsor's last update on 19 Sep 2019. 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 Singapore. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 19 Sep 2019.