The Effect of Direct Referral for Fast CT Scan in Early Lung Cancer Detection in General Practice

Lung Cancer Clinical Trial

Official title:

The Effect of Direct Referral for Fast CT Scan in Early Lung Cancer Detection in General Practice. Clinical, Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527214
• Other study ID #: DirectCT
• Status: Completed
• Phase: N/A
• First received: January 20, 2012
• Last updated: August 5, 2013
• Start date: November 2011
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Centre for Public HealthDenmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all practices referring to the Department of Pulmonary Medicine, Aarhus University Hospital.

Exclusion Criteria:

• former lung cancer patients.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• CT scan and education
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.

Locations

Country	Name	City	State
Denmark	University of Aarhus	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delay	Time from first presentation i General Practice to the patient obtains the diagnosis	12 month	No
Secondary	Referral pattern (use of fast-track packet)		12 month	No
Secondary	Primary use of CT		12 month	No
Secondary	1-year mortality.		24 month	No

External Links

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