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OpenTrials
Completed

NCT Number: NCT01527214

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Aarhus

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • former lung cancer patients.

Treatment and study plan

CT scan and education

Radiation

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.

Primary outcomes

  1. Delay

    Time frame: 12 month

    Time from first presentation i General Practice to the patient obtains the diagnosis

Secondary outcomes

  1. Referral pattern (use of fast-track packet)

    Time frame: 12 month

  2. Primary use of CT

    Time frame: 12 month

  3. 1-year mortality.

    Time frame: 24 month

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 6, 2012
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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