Lung CancerNCT01779726
Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis
A study testing CT scan before chest physician and Usual diagnostic workup in people with Lung Cancer, run by University of Aarhus at 2 sites in Denmark.
Trial summary
Annually, 4,200 new cases of lung cancer are diagnosed in Denmark. The stage of the disease is an important prognostic factor as an advanced stage reduces the opportunity for surgical intervention and other curative treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- CT scan before chest physician and Usual diagnostic workup
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2012to Jan 2014
- 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 patients referred to fast track evaluation (lung department, Aarhus university hospital) from primary care.
Who cannot join
- Not referred from general practice
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University
Aarhus, Aarhus, 8000
Department of lung medicine, Aarhus University Hospital
Aarhus, Aarhus, 8000
About this study
Official title: Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis. A Randomised Controlled Trial.
Annually, 4,200 new cases of lung cancer are diagnosed in Denmark. The stage of the disease is an important prognostic factor as an advanced stage reduces the opportunity for surgical intervention and other curative treatment. In denmark, as in many other countries, a fast track evaluation for lung cancer has been introduced in 2008.
When the general practitioners refer patients through the fast track, the majority of patients make their first visit to the Department of Pulmonary Medicine. After this visit, further investigation is initiated, which is often a CT scan of the chest and the upper abdomen. We dont know Whether this is the most appropriate organisation.
Read more
The aim of this project is to evaluate the way lung cancer patients are examined through the fast track and the impact of chest CT before an evaluation by a chest physician.
Investigators want to randomise all patients referred for the existing fast track to either direct CT scan of chest and upper abdomen or to evaluation by the chest physician, in order to test:
- Fast track performance measured by number of CT scans and chest physician specialist time per diagnosis, and whether there is a difference between the intervention and the control group.
- Conditions
- Lung Cancer
- Being tested
- CT scan before chest physician, Usual diagnostic workup
- Keywords
- Organization, of fast track
- 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 before chest physicianRadiation
Patients referred to department of lung medicine are randomised according to the month of birth. Patients born in even months are CT scan before a consultation with a chest physician
Usual diagnostic workupRadiation
Patients born in odd months seen in the department of lung medicine by a chest physician and maybe then CT scanned (usual workup practice according to the fast track evaluation)
| Study group | Role | What they receive |
|---|---|---|
| CT scan before chest physician | Experimental | CT scan before chest physician Receives: Radiation: CT scan before chest physician |
| Usual diagnostic workup | Active comparator | Usual diagnostic workup Receives: Radiation: Usual diagnostic workup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest physician time
Time (in minutes) spent by a chest physician pr patient
Measured: 2013
Secondary outcomes (1)
Satisfaction with new organisation
Measured with a qualitative focus interview with staff a the Department of lung medicine (doctors, nurses and secretary).
Measured: 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Vedsted, M.D., Prof., Principal investigator, The Research Unit for General Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779726
- Sponsor's protocol ID
- 118/2011
- Status last verified
- Aug 2013
- First submitted
- 28 Jan 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Guldbrandt LM, Fenger-Gron M, Folkersen BH, Rasmussen TR, Vedsted P. Reduced specialist time with direct computed tomography for suspected lung cancer in primary care. Dan Med J. 2013 Dec;60(12):A4738.
PubMed 24355447
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT01779726
- Acronym / sponsor ID
- 118/2011
- Conditions
- Lung Cancer
- Keywords
- Organization, of fast track
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Jan 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.
Annually, 4,200 new cases of lung cancer are diagnosed in Denmark. The stage of the disease is an important prognostic factor as an advanced stage reduces the opportunity for surgical intervention and other curative treatment. In denmark, as in many other countries, a fast track evaluation for lung cancer has been introduced in 2008.
When the general practitioners refer patients through the fast track, the majority of patients make their first visit to the Department of Pulmonary Medicine. After this visit, further investigation is initiated, which is often a CT scan of the chest and the upper abdomen. We dont know Whether this is the most appropriate organisation.
The aim of this project is to evaluate the way lung cancer patients are examined through the fast track and the impact of chest CT before an evaluation by a chest physician.
Investigators want to randomise all patients referred for the existing fast track to either direct CT scan of chest and upper abdomen or to evaluation by the chest physician, in order to test:
- Fast track performance measured by number of CT scans and chest physician specialist time per diagnosis, and whether there is a difference between the intervention and the control group.
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 before chest physician | Experimental | Radiation: CT scan before chest physicianCT scan before chest physician |
| Usual diagnostic workup | Active comparator | Radiation: Usual diagnostic workupUsual diagnostic workup |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients referred to fast track evaluation (lung department, Aarhus university hospital) from primary care.
Key exclusion criteria (1 listed)
- Not referred from general practice
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 before chest physicianPatients referred to department of lung medicine are randomised according to the month of birth. Patients born in even months are CT scan before a consultation with a chest physician | Radiation | CT scan before chest physician |
| Usual diagnostic workupPatients born in odd months seen in the department of lung medicine by a chest physician and maybe then CT scanned (usual workup practice according to the fast track evaluation) | Radiation | Usual diagnostic workup |
Primary outcome
Chest physician time
Time frame: 2013
Time (in minutes) spent by a chest physician pr patient
1 secondary outcome
Satisfaction with new organisation
Time frame: 2013
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 3 Dec 2014.
- Derived from this study: PubMed 24355447Guldbrandt LM, Fenger-Gron M, Folkersen BH, Rasmussen TR, Vedsted P. Reduced specialist time with direct computed tomography for suspected lung cancer in primary care. Dan Med J. 2013 Dec;60(12):A4738.
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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, M.D., Prof. principal investigator
The Research Unit for General Practice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan before chest physician and Usual diagnostic workup in people with Lung Cancer, run by University of Aarhus at 2 sites 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Chest physician time (time frame: 2013). 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 NCT01779726, which also lists 1 linked publication.
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 3 Dec 2014.