Early Cancer Detection Test - Lung Cancer Scotland
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Intervention
Name: Early CDT Lung blood test
Type: Biological
Overall Status
Recruiting
Summary
HYPOTHESIS In a high risk population the EarlyCDT-Lung test reduces the incidence of late stage tumours;3 / 4 / Unclassified (U) at diagnosis compared to normal clinical practice.
Detailed Description
AIMS To assess the effectiveness of EarlyCDT-Lung test in increasing early stage lung cancer detection, thereby reducing the rate of late stage (3 / 4 / U) presentation, compared to normal clinical practice; to assess the cost-effectiveness of EarlyCDT-Lung test compared to normal clinical practice; to assess the effectiveness of EarlyCDT-Lung test in reducing adverse outcomes including potential psychological and behavioural consequences.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 75 Years
Minimum Age: 50 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Participant is willing and able to give informed consent for participation in the study

2. Male or female aged 50 years to 75 years

3. Current or Ex-smoker with at least 20 year pack history

4. or Less than 20 year pack history but with family history of lung cancer in a 1st degree relative (mother, father, sister, brother, child)

5. ECOG Status: 0, 1 and 2 (Eastern Co-operative Oncology Group) Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours

6. Geographical postal sectors of:

NHS Geographical Area Eligible Postcodes Tayside DD1 - DD11, PH1-PH3 , PH6-PH8, PH10, PH11, PH13, PH15 & PH16 Greater Glasgow & Clyde G1-G5, G11 -G15, G20-G22, G31-34, G40 -G46, G51- G53, G60-G62 &G64, G66 & G69, G72 & G73, G76-G78, G81-G83 PA1-PA8 (except PA6), PA11-PA16 & PA19

Exclusion Criteria:

1. History of any cancer other than non-melanomatous skin cancer, cervical cancer in situ.

2. Symptoms suggestive of lung cancer within past 6 months (haemoptysis, unintentional weight loss (at least 5% in preceding 6 months).

3. Patients for whom the GP considers invitation to the study would cause undue distress.

4. Patients with other terminal disease.

5. Patients on prolonged / continuous use (> 3months) of cytotoxic/ immuno-suppressant drugs eg: Cyclophosphamide. Monotherapy using glucocorticoids/ steroids eg prednisolone is NOT an exclusion criteria.
Locations
NHS Tayside
Dundee, Tayside, United Kingdom
Status: Recruiting
Contact: Stephanie L Gallant - 01382 383994 - s.gallant@dundee.ac.uk
NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
Status: Recruiting
Contact: Karen Duffy - 0141 2329525 - karen.duffy@ggc.scot.nhs.uk
Start Date
August 2013
Completion Date
August 2018
Sponsors
Cheryl Hume
Source
University of Dundee
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page