Lung CancerNCT03522090
Retrospective Comparative Study of Routine Lower Neck CT in the Staging and Diagnosis of Lung Cancer Across Two Cohorts
An observational study of Lung Cancer and Supraclavicular Lymphadenopathy, run by University College Hospital Galway.
Trial summary
This is a study comparing routine inclusion of the lower neck in initial CT thorax in patients with suspected lung cancer to not including it. The study aims to assess whether such an intervention reduces the number of invasive investigations required to achieve a final diagnosis and clinical stage and whether it… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Supraclavicular Lymphadenopathy
- What is being tested?
- lower neck CT
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 30 Jan 2019
- 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
- Adult, Older adult
Study population: Patients initially seen with suspected lung cancer
Who may be able to join
- Male or female age > 18 years
- Pathologically confirmed primary lung cancer
- Intrathoracic N2 and or N3 disease on CT defined as lymph node with short diameter > 10 mm
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
This is a study comparing routine inclusion of the lower neck in initial CT thorax in patients with suspected lung cancer to not including it. The study aims to assess whether such an intervention reduces the number of invasive investigations required to achieve a final diagnosis and clinical stage and whether it improves the detection of cervical lymph nodes involvement by lung cancer.
Read the detailed description
Two practices currently exist regarding the role of lower neck CT in patients with suspected lung cancer but with little evidence for either. Routine lower neck CT is potentially associated with benefits of higher detection of neck lymphadenopathy leading to better staging, less invasive procedure with positive implications for patients experience and care. The potential harms are delay in diagnosis due to false positive findings and radiation exposure. There is limited evidence in this area so this study will potentially provide evidence to inform health policy decisions based on the risk benefit balance.
This is a retrospective comparative study to assess the real-life impact of routine lower neck CT on the diagnostic and staging work up of patients with suspected lung cancer across two cohorts.
- Conditions
- Lung Cancer, Supraclavicular Lymphadenopathy
- Being tested
- lower neck CT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower neck CTDiagnostic test
Computerised tomography of the lower neck done as part of initial CT thorax and lower abdomen
| Study group | Role | What they receive |
|---|---|---|
| No neck CT | Cohort of patients with suspected lung cancer where the lower neck is not routinely included in CT Receives: Diagnostic Test: lower neck CT | |
| Neck CT | Cohort of patients with suspected lung cancer where the lower neck is routinely included in CT Receives: Diagnostic Test: lower neck CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of pathologically confirmed malignant supraclavicular lymph node
evidence of malignancy consistent with lung cancer on fine needle aspiration or core biopsy
Measured: 60 days from initial CT
Secondary outcomes (3)
Number of diagnostic procedures performed per patient
number of invasive procedures used to obtain tissue to achieve diagnosis and/or stage
Measured: 60 days from initial CT Thorax
Proportion of patients who underwent more than one diagnostic procedures
Measured: 60 days from initial CT Thorax
Proportion of patients who underwent Endobronchial Ultrasound (EBUS)
Measured: 60 days from initial CT Thorax
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Jul 2018 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Jan 2019 (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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Plymouth NHS Trust
- Responsible party
- Principal investigator, Mohammed Ahmed, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522090
- Sponsor's protocol ID
- V1.0
- Status last verified
- Apr 2018
- First submitted
- 30 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Comparative Study of Routine Lower Neck CT in the Staging and Diagnosis of Lung Cancer Across Two Cohorts
- ClinicalTrials.gov ID
- NCT03522090
- Acronym / sponsor ID
- V1.0
- Conditions
- Lung Cancer, Supraclavicular Lymphadenopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Collaborators
- University Hospital Plymouth NHS Trust
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 11 May 2018 (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.
This is a study comparing routine inclusion of the lower neck in initial CT thorax in patients with suspected lung cancer to not including it. The study aims to assess whether such an intervention reduces the number of invasive investigations required to achieve a final diagnosis and clinical stage and whether it improves the detection of cervical lymph nodes involvement by lung cancer.
Detailed description
Two practices currently exist regarding the role of lower neck CT in patients with suspected lung cancer but with little evidence for either. Routine lower neck CT is potentially associated with benefits of higher detection of neck lymphadenopathy leading to better staging, less invasive procedure with positive implications for patients experience and care. The potential harms are delay in diagnosis due to false positive findings and radiation exposure. There is limited evidence in this area so this study will potentially provide evidence to inform health policy decisions based on the risk benefit balance.
This is a retrospective comparative study to assess the real-life impact of routine lower neck CT on the diagnostic and staging work up of patients with suspected lung cancer across two cohorts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No neck CT | – | Diagnostic Test: lower neck CTCohort of patients with suspected lung cancer where the lower neck is not routinely included in CT |
| Neck CT | – | Diagnostic Test: lower neck CTCohort of patients with suspected lung cancer where the lower neck is routinely included in CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients initially seen with suspected lung cancer
Key inclusion criteria (3 listed)
- Male or female age > 18 years
- Pathologically confirmed primary lung cancer
- Intrathoracic N2 and or N3 disease on CT defined as lymph node with short diameter > 10 mm
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| lower neck CTComputerised tomography of the lower neck done as part of initial CT thorax and lower abdomen | Diagnostic test | Neck CT, No neck CT |
Primary outcome
Proportion of pathologically confirmed malignant supraclavicular lymph node
Time frame: 60 days from initial CT
evidence of malignancy consistent with lung cancer on fine needle aspiration or core biopsy
3 secondary outcomes
Number of diagnostic procedures performed per patient
Time frame: 60 days from initial CT Thorax
Proportion of patients who underwent more than one diagnostic procedures
Time frame: 60 days from initial CT Thorax
Proportion of patients who underwent Endobronchial Ultrasound (EBUS)
Time frame: 60 days from initial CT Thorax
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Individual participant dataSharing planned: No
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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?
An observational study of Lung Cancer and Supraclavicular Lymphadenopathy, run by University College Hospital Galway.
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 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 11 May 2018. 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 Mohammed Ahmed, Dr (0035391524222, jamaleldeen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of pathologically confirmed malignant supraclavicular lymph node (time frame: 60 days from initial CT). 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 11 May 2018.