Lung CancerNCT01972386
EBUS/Spectrum Analysis
An observational study of Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
To evaluate the clinical benefit of spectrum analysis of endobronchial ultrasound images of lymph nodes during EBUS TBNA for lymph node staging in patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Spectrum Image Analysis using a Linear Array Ultrasound Bronchoscope
- Type of treatment
- Medical device
- How many people
- 122 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Jan 2016
- 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: Patients with lung cancer or suspected lung cancer who undergo EBUS TBNA for lymph node staging.
Who may be able to join
- Ages 18 years or older
- Patients with known or suspected lung cancer who require EBUS-TBNA for lymph node staging
Who cannot join
- Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy
- Inability to give informed consent
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spectrum Image Analysis of Lymph Nodes During Endobronchial Ultrasound-Guided (EBUS) Transbronchial Needle Aspiration (TBNA) in Patients With Lung Cancer
To evaluate the clinical benefit of spectrum analysis of endobronchial ultrasound images of lymph nodes during EBUS TBNA for lymph node staging in patients with lung cancer.
- Conditions
- Lung Cancer
- Being tested
- Spectrum Image Analysis using a Linear Array Ultrasound 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.
Spectrum Image Analysis using a Linear Array Ultrasound BronchoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Spectrum Image Analysis | Not described Receives: Device: Spectrum Image Analysis using a Linear Array Ultrasound Bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph Node Staging
The lymph node staging will be determined by the pathology report of the biopsy taken from the patients lymph node(s).
Measured: Pathology report will be completed as soon as possible after the procedure. (Within one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionJan 2016
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 University Health Network, TorontoThe 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972386
- Sponsor's protocol ID
- 12-5898-CE
- Status last verified
- Feb 2018
- First submitted
- 8 Oct 2013
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectrum Image Analysis of Lymph Nodes During Endobronchial Ultrasound-Guided (EBUS) Transbronchial Needle Aspiration (TBNA) in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT01972386
- Acronym / sponsor ID
- 12-5898-CE
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Oct 2013 (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 evaluate the clinical benefit of spectrum analysis of endobronchial ultrasound images of lymph nodes during EBUS TBNA for lymph node staging in patients with lung cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spectrum Image Analysis | – | Device: Spectrum Image Analysis using a Linear Array Ultrasound Bronchoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung cancer or suspected lung cancer who undergo EBUS TBNA for lymph node staging.
Key inclusion criteria (2 listed)
- Ages 18 years or older
- Patients with known or suspected lung cancer who require EBUS-TBNA for lymph node staging
Key exclusion criteria (3 listed)
- Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy
- Inability to give informed consent
- Patients who are pregnant
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 |
|---|---|---|
| Spectrum Image Analysis using a Linear Array Ultrasound Bronchoscope | Device | Spectrum Image Analysis |
Primary outcome
Lymph Node Staging
Time frame: Pathology report will be completed as soon as possible after the procedure. (Within one year)
The lymph node staging will be determined by the pathology report of the biopsy taken from the patients lymph node(s).
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 23 Feb 2018.
Related trials for Lung Cancer
Active, not recruitingPhase 2
Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy
Radiation of Neurocranial Region
RecruitingPhase 3
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Non-small Cell Lung Cancer, NSCLC
RecruitingPhase 3
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma
RecruitingPhase 3
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Carcinoma, Non-Small-Cell Lung
Not yet recruitingPhase 1/2
DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma
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 University Health Network, Toronto at 1 site in Canada.
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 3 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 23 Feb 2018. 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 Canada. 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.
What does the primary outcome measure?
Lymph Node Staging (time frame: Pathology report will be completed as soon as possible after the procedure. (Within one year)). 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 23 Feb 2018.