Early Cancer Detection Test - Lung Cancer Scotland (ECLS)
October 11, 2018 updated by: Stuart Schembri
Detection in Blood of Autoantibodies to Tumour Antigens as a Case-finding Method in Lung Cancer Using the EarlyCDT-Lung Test
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12210
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Glasgow, United Kingdom
- NHS Greater Glasgow & Clyde
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Wishaw, United Kingdom
- NHS Lanarkshire
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Tayside
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Dundee, Tayside, United Kingdom, DD1 9SY
- NHS Tayside
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
46 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study
- Male or female aged 50 years to 75 years
- Current or Ex-smoker with at least 20 year pack history
- or Less than 20 year pack history but with family history of lung cancer in a 1st degree relative (mother, father, sister, brother, child)
- 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
- 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:
- History of any cancer other than non-melanomatous skin cancer, cervical cancer in situ.
- Symptoms suggestive of lung cancer within past 6 months (haemoptysis, unintentional weight loss (at least 5% in preceding 6 months).
- Patients for whom the GP considers invitation to the study would cause undue distress.
- Patients with other terminal disease.
- Patients on prolonged / continuous use (> 3months) of cytotoxic/ immuno-suppressant drugs eg: Cyclophosphamide. Monotherapy using glucocorticoids/ steroids eg prednisolone is NOT an exclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
participants monitored for 10 years for lung cancer incidence.
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Active Comparator: Early CDT Lung Test
Early CDT lung blood test
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The EarlyCDT-Lung Test is an early detection test designed to assist in lung cancer risk assessment and detection in the earliest stages of the disease.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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to assess the effectiveness of EarlyCDT-Lung test in reducing the incidence of patients with late-stage lung cancer at diagnosis, compared with standard clinical practice;
Time Frame: 24 months
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difference at 24 months after randomisation, between the number of patients with stage 3, 4 or unclassified lung cancer at diagnosis in the intervention arm, and those in the control arm;
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frank Sullivan, MbChB, University of Dundee
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Madurasinghe VW, Bower P, Eldridge S, Collier D, Graffy J, Treweek S, Knapp P, Parker A, Rick J, Salisbury C, Man MS, Torgerson D, Sheridan R, Sullivan F, Cockayne S, Dack C. Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets. BMC Med. 2021 Sep 23;19(1):218. doi: 10.1186/s12916-021-02086-2.
- Sullivan FM, Mair FS, Anderson W, Armory P, Briggs A, Chew C, Dorward A, Haughney J, Hogarth F, Kendrick D, Littleford R, McConnachie A, McCowan C, McMeekin N, Patel M, Rauchhaus P, Ritchie L, Robertson C, Robertson J, Robles-Zurita J, Sarvesvaran J, Sewell H, Sproule M, Taylor T, Tello A, Treweek S, Vedhara K, Schembri S; Early Diagnosis of Lung Cancer Scotland (ECLS) Team. Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging. Eur Respir J. 2021 Jan 14;57(1):2000670. doi: 10.1183/13993003.00670-2020. Print 2021 Jan.
- Parker A, Knapp P, Treweek S, Madhurasinghe V, Littleford R, Gallant S, Sullivan F, Schembri S, Rick J, Graffy J, Collier DJ, Eldridge S, Kennedy A, Bower P. The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial. Trials. 2018 Sep 18;19(1):503. doi: 10.1186/s13063-018-2896-9.
- Sullivan FM, Farmer E, Mair FS, Treweek S, Kendrick D, Jackson C, Robertson C, Briggs A, McCowan C, Bedford L, Young B, Vedhara K, Gallant S, Littleford R, Robertson J, Sewell H, Dorward A, Sarvesvaran J, Schembri S. Detection in blood of autoantibodies to tumour antigens as a case-finding method in lung cancer using the EarlyCDT(R)-Lung Test (ECLS): study protocol for a randomized controlled trial. BMC Cancer. 2017 Mar 11;17(1):187. doi: 10.1186/s12885-017-3175-y.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
August 31, 2018
Study Completion (Actual)
August 31, 2018
Study Registration Dates
First Submitted
August 15, 2013
First Submitted That Met QC Criteria
August 19, 2013
First Posted (Estimate)
August 20, 2013
Study Record Updates
Last Update Posted (Actual)
October 16, 2018
Last Update Submitted That Met QC Criteria
October 11, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013ON07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
paticipant activity nearing closure
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.