Lung CancerNCT01527214
The Effect of Direct Referral for Fast CT Scan in Early Lung Cancer Detection in General Practice
A study testing CT scan and education in people with Lung Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background: The primary investigation of lung cancer (LC) is for 85% of the cases conducted through General Practice, sadly it tends to take a relatively long time from first time the patient is seen by their General Practitioner and until they are diagnosed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- CT scan and education
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Jul 2013
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all practices referring to the Department of Pulmonary Medicine, Aarhus University Hospital.
Who cannot join
- former lung cancer patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Direct Referral for Fast CT Scan in Early Lung Cancer Detection in General Practice. Clinical, Randomised Trial
Background: The primary investigation of lung cancer (LC) is for 85% of the cases conducted through General Practice, sadly it tends to take a relatively long time from first time the patient is seen by their General Practitioner and until they are diagnosed. LC symptoms are common, but usual because of benign diseases. Only 33% of LC patients presenting with alarm symptoms. On average a General Practitioner in Denmark sees only one patient with newly diagnosed lung cancer a year and the doctor will therefore get the clinical experience that when they refer a patient, test often come out negative and they therefore fail to refer and delay will increase - with a poorer prognosis as a result. Centrally in the diagnosis is conventional chest X-ray, which unfortunately is inefficient in many cases, while CT scanning has proven effective even for small tumors.
Hypothesis and aims: The project has three main hypotheses to be tested 1) the GP's use of cancer fast-track and detection of suspected lung cancer can be optimized in relation to interpretation of symptoms and subsequent referral practices and radiological investigation. 2) General Practitioners with special training can change the referral routines and 3) direct access to fast CT scanning leads to earlier diagnosis of lung cancer.
Read more
Methods: The first part of the study is a register-based study of lung cancer patients' road to diagnosis, based on a database of newly diagnosed cancer patients in a year. Second part of the study is a clinical, randomized study of the effect of referral directly to fast chest CT scan. Primary endpoint is delay, secondary endpoints are referral pattern (use of fast-track packet), primary use of CT and 1-year mortality. Furthermore side effects, including patient groups with increased delay.
The study will contribute new knowledge to the way GP's interpret symptoms, the way they refer their patients when they suspect cancer, their use of diagnostic imaging and cancer fast-track pathways. It will then provide a unique opportunity to create the necessary knowledge about the effects of direct referral to fast CT scan and it might be a decision aid whether to open for direct CT scan in General Practice for a group of patients.
- Conditions
- Lung Cancer
- Being tested
- CT scan and education
- Keywords
- Lung cancer, early detection, CT scan, General Practice, Effect of Computed Tomography scans, Clinical medical education
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scan and educationRadiation
GPs get direct access to chest CT scans for their patients. The GPs will be offered special training related to the diagnosis of lung cancer in general practice.This will be done by offering training sessions and written material. The training will include risk groups, alarm symptoms, symptom complexes and interpretation of CT scan descriptions.
| Study group | Role | What they receive |
|---|---|---|
| CT scan and education | Experimental | All general practices referring to the Department of Pulmonary Medicine, Aarhus University Hospital.Randomized 1:1. In the intervention group, GPs continue to refer to the lung cancer fast track when indicated. In addition, they are allowed to refer directly to a rapid chest CT scan in cases where they find reasons to examine the patient for lung diseases without having sufficient suspicion of lung cancer to refer the patient to the lung cancer fast track. The GPs will be offered special training related to the diagnosis of lung cancer in general practice before the new referral option is introduced. This will be done by offering training sessions and written material. Receives: Radiation: CT scan and education |
| Control | No intervention | Cluster eligibility: all practices referring to the Department of Pulmonary Medicine, Aarhus University Hospital. Randomized 1:1. Control arm continues with the usual referral pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay
Time from first presentation i General Practice to the patient obtains the diagnosis
Measured: 12 month
Secondary outcomes (3)
Referral pattern (use of fast-track packet)
Measured: 12 month
Primary use of CT
Measured: 12 month
1-year mortality.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Vedsted, Professor, Principal investigator, The Research Unit for Generel Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527214
- Sponsor's protocol ID
- DirectCT
- Status last verified
- Aug 2013
- First submitted
- 20 Jan 2012
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Guldbrandt LM, Fenger-Gron M, Rasmussen TR, Rasmussen F, Meldgaard P, Vedsted P. The effect of direct access to CT scan in early lung cancer detection: an unblinded, cluster-randomised trial. BMC Cancer. 2015 Nov 25;15:934. doi: 10.1186/s12885-015-1941-2.
PubMed 26608727Guldbrandt LM, Rasmussen TR, Rasmussen F, Vedsted P. Implementing direct access to low-dose computed tomography in general practice--method, adaption and outcome. PLoS One. 2014 Nov 10;9(11):e112162. doi: 10.1371/journal.pone.0112162. eCollection 2014.
PubMed 25383780
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Direct Referral for Fast CT Scan in Early Lung Cancer Detection in General Practice. Clinical, Randomised Trial
- ClinicalTrials.gov ID
- NCT01527214
- Acronym / sponsor ID
- DirectCT
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, early detection, CT scan, General Practice, Effect of Computed Tomography scans, Clinical medical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Feb 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.
Background: The primary investigation of lung cancer (LC) is for 85% of the cases conducted through General Practice, sadly it tends to take a relatively long time from first time the patient is seen by their General Practitioner and until they are diagnosed. LC symptoms are common, but usual because of benign diseases. Only 33% of LC patients presenting with alarm symptoms. On average a General Practitioner in Denmark sees only one patient with newly diagnosed lung cancer a year and the doctor will therefore get the clinical experience that when they refer a patient, test often come out negative and they therefore fail to refer and delay will increase - with a poorer prognosis as a result. Centrally in the diagnosis is conventional chest X-ray, which unfortunately is inefficient in many cases, while CT scanning has proven effective even for small tumors.
Hypothesis and aims: The project has three main hypotheses to be tested 1) the GP's use of cancer fast-track and detection of suspected lung cancer can be optimized in relation to interpretation of symptoms and subsequent referral practices and radiological investigation. 2) General Practitioners with special training can change the referral routines and 3) direct access to fast CT scanning leads to earlier diagnosis of lung cancer.
Methods: The first part of the study is a register-based study of lung cancer patients' road to diagnosis, based on a database of newly diagnosed cancer patients in a year. Second part of the study is a clinical, randomized study of the effect of referral directly to fast chest CT scan. Primary endpoint is delay, secondary endpoints are referral pattern (use of fast-track packet), primary use of CT and 1-year mortality. Furthermore side effects, including patient groups with increased delay.
The study will contribute new knowledge to the way GP's interpret symptoms, the way they refer their patients when they suspect cancer, their use of diagnostic imaging and cancer fast-track pathways. It will then provide a unique opportunity to create the necessary knowledge about the effects of direct referral to fast CT scan and it might be a decision aid whether to open for direct CT scan in General Practice for a group of patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT scan and education | Experimental | Radiation: CT scan and educationAll general practices referring to the Department of Pulmonary Medicine, Aarhus University Hospital.Randomized 1:1. In the intervention group, GPs continue to refer to the lung cancer fast track when indicated. In addition, they are allowed to refer directly to a rapid chest CT scan in cases where they find reasons to examine the patient for lung diseases without having sufficient suspicion of lung cancer to refer the patient to the lung cancer fast track. The GPs will be offered special training related to the diagnosis of lung cancer in general practice before the new referral option is introduced. This will be done by offering training sessions and written material. |
| Control | No intervention | –Cluster eligibility: all practices referring to the Department of Pulmonary Medicine, Aarhus University Hospital. Randomized 1:1. Control arm continues with the usual referral pattern |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all practices referring to the Department of Pulmonary Medicine, Aarhus University Hospital.
Key exclusion criteria (1 listed)
- former lung cancer patients.
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 |
|---|---|---|
| CT scan and educationGPs get direct access to chest CT scans for their patients. The GPs will be offered special training related to the diagnosis of lung cancer in general practice.This will be done by offering training sessions and written material. The training will include risk groups, alarm symptoms, symptom complexes and interpretation of CT scan descriptions. | Radiation | CT scan and education |
Primary outcome
Delay
Time frame: 12 month
Time from first presentation i General Practice to the patient obtains the diagnosis
3 secondary outcomes
Referral pattern (use of fast-track packet)
Time frame: 12 month
Primary use of CT
Time frame: 12 month
1-year mortality.
Time frame: 24 month
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 7 Aug 2013.
- Derived from this study: PubMed 26608727Guldbrandt LM, Fenger-Gron M, Rasmussen TR, Rasmussen F, Meldgaard P, Vedsted P. The effect of direct access to CT scan in early lung cancer detection: an unblinded, cluster-randomised trial. BMC Cancer. 2015 Nov 25;15:934. doi: 10.1186/s12885-015-1941-2.
- Derived from this study: PubMed 25383780Guldbrandt LM, Rasmussen TR, Rasmussen F, Vedsted P. Implementing direct access to low-dose computed tomography in general practice--method, adaption and outcome. PLoS One. 2014 Nov 10;9(11):e112162. doi: 10.1371/journal.pone.0112162. eCollection 2014.
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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.
Peter Vedsted, Professor principal investigator
The Research Unit for Generel Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan and education in people with Lung Cancer, run by University of Aarhus at 1 site in Denmark.
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 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: finished, as of the sponsor's last update on 7 Aug 2013. 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 Denmark. 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?
Delay (time frame: 12 month). 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 NCT01527214, which also lists 2 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 7 Aug 2013.