Lung Cancer MetastaticNCT03970564
Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer
An observational study of Lung Cancer Metastatic and Nodes, Lung, run by University College Hospital Galway at 1 site in Ireland.
Trial summary
This is a study of routine neck ultrasound performed by respiratory physicians in patients with mediastinal lymphadenopathy and suspected lung cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer Metastatic, Nodes, Lung
- What is being tested?
- Neck ultrasound guide lymph node sampling
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 21 Oct 2016to 30 May 2018
- 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 Any age
- Child, Adult, Older adult
Study population: Patients with suspected and later on confirmed lung cancer with evidence of enlarged mediastinal lymph node(s) measuring > 10 mm in short diameter on Computerised Tomography
Who may be able to join
- Suspected and later on confirmed lung cancer
- Presence of at least one mediastinal lymph node measuring > 10 mm in short diameter on computerised Tomography
Who cannot join
- Age <18
- History any malignancy apart from non-melanomatous skin cancer
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Routine Neck Ultrasound by Respiratory Physicians in the Diagnosis and Staging of Patients With Lung Cancer and Mediastinal Lymphadenopathy, a Prospective Pilot Study
This is a study of routine neck ultrasound performed by respiratory physicians in patients with mediastinal lymphadenopathy and suspected lung cancer
Read the detailed description
In the first phase of the study a respiratory physician was trained to perform neck ultrasound and needle sampling of enlarged cervical lymph nodes according to preset criteria. In the second phase patients with suspected lung cancer and enlarged mediastinal lymph nodes underwent routine neck ultrasound and enlarged cervical lymph nodes were sampled using fine needle and or core needle biopsy.
The outcomes of interest in the study were the rate of malignant cervical lymphadenopathy defined as pathological evidence of cancer in neck lymph node samples consistent with a lung primary, adequacy of needle sampling, patient reported experience assessed by a visual analogue of discomfort associated with needle neck sampling and EBUS, and the proportion of patients that had nodal upstaging
- Conditions
- Lung Cancer Metastatic, Nodes, Lung
- Being tested
- Neck ultrasound guide lymph node sampling
- Keywords
- ultrasound, lymphadenopathy, lung cancer
- Medical subject headings
- Lymphadenopathy, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck ultrasound guide lymph node samplingDiagnostic test
Neck ultrasound done first and lymph nodes larger than 5 mm that are technically feasible are sampled using fine needle aspiration and/or core needle biopsy
| Study group | Role | What they receive |
|---|---|---|
| Suspected lung cancer | Suspected and later on confirmed lung cancer with evidence of mediastinal lymphadenopathy on computerised tomography Receives: Diagnostic Test: Neck ultrasound guide lymph node sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of lymph node sampling
Presence of lymphocytes or malignant cells in biopsy samples
Measured: 7 days
Secondary outcomes (2)
Proportion of patients with malignant cervical lymphadenopathy
Presence of malignant cells consistent with lung cancer in cervical lymph node samples
Measured: 7 days
Proportion of patients with nodal status upstaged
Defined as a change from cN2 to cN3 according to the 8th edition of the Tumour Node Metastasis TNM staging system
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start21 Oct 2016
- Primary completion21 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer MetastaticStudies 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Collaborators
- European Respiratory Society
- Responsible party
- Principal investigator, Mohammed Ahmed, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970564
- Sponsor's protocol ID
- Version 01
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 31 May 2019
- 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 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Neck Ultrasound by Respiratory Physicians in the Diagnosis and Staging of Patients With Lung Cancer and Mediastinal Lymphadenopathy, a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT03970564
- Acronym / sponsor ID
- Version 01
- Conditions
- Lung Cancer Metastatic, Nodes, Lung
- Keywords
- ultrasound, lymphadenopathy, lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Collaborators
- European Respiratory Society
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 31 May 2019 (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 of routine neck ultrasound performed by respiratory physicians in patients with mediastinal lymphadenopathy and suspected lung cancer
Detailed description
In the first phase of the study a respiratory physician was trained to perform neck ultrasound and needle sampling of enlarged cervical lymph nodes according to preset criteria. In the second phase patients with suspected lung cancer and enlarged mediastinal lymph nodes underwent routine neck ultrasound and enlarged cervical lymph nodes were sampled using fine needle and or core needle biopsy.
The outcomes of interest in the study were the rate of malignant cervical lymphadenopathy defined as pathological evidence of cancer in neck lymph node samples consistent with a lung primary, adequacy of needle sampling, patient reported experience assessed by a visual analogue of discomfort associated with needle neck sampling and EBUS, and the proportion of patients that had nodal upstaging
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected lung cancer | – | Diagnostic Test: Neck ultrasound guide lymph node samplingSuspected and later on confirmed lung cancer with evidence of mediastinal lymphadenopathy on computerised tomography |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected and later on confirmed lung cancer with evidence of enlarged mediastinal lymph node(s) measuring > 10 mm in short diameter on Computerised Tomography
Key inclusion criteria (2 listed)
- Suspected and later on confirmed lung cancer
- Presence of at least one mediastinal lymph node measuring > 10 mm in short diameter on computerised Tomography
Key exclusion criteria (3 listed)
- Age <18
- History any malignancy apart from non-melanomatous skin cancer
- Inability to give informed consent
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 |
|---|---|---|
| Neck ultrasound guide lymph node samplingNeck ultrasound done first and lymph nodes larger than 5 mm that are technically feasible are sampled using fine needle aspiration and/or core needle biopsy | Diagnostic test | Suspected lung cancer |
Primary outcome
Adequacy of lymph node sampling
Time frame: 7 days
Presence of lymphocytes or malignant cells in biopsy samples
2 secondary outcomes
Proportion of patients with malignant cervical lymphadenopathy
Time frame: 7 days
Proportion of patients with nodal status upstaged
Time frame: 7 days
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 31 May 2019.
- 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.
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 Metastatic and Nodes, Lung, run by University College Hospital Galway at 1 site in Ireland.
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 31 May 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 Ireland. 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?
Adequacy of lymph node sampling (time frame: 7 days). 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 31 May 2019.