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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | participants monitored for 10 years for lung cancer incidence. | |
| Early CDT Lung Test | Active Comparator | Early CDT lung blood test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early CDT Lung blood test | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | 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; | 24 months |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Sullivan, MbChB | University of Dundee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Tayside | Dundee | Tayside | DD1 9SY | United Kingdom | ||
| NHS Greater Glasgow & Clyde |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40142924 | Derived | Romeikat NL, Sullivan F, Daly F, Kong W. The Importance of Comorbidities at Baseline and 5-Year Follow-Up in a Lung Cancer Biomarker Screening Trial. J Clin Med. 2025 Mar 20;14(6):2116. doi: 10.3390/jcm14062116. | |
| 34551765 | Derived | 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. |
| Label | URL |
|---|---|
| Study website | View source |
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paticipant activity nearing closure
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Glasgow |
| United Kingdom |
| NHS Lanarkshire | Wishaw | United Kingdom |
| 32732334 | Derived | 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. |
| 30227890 | Derived | 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. |
| 28284200 | Derived | 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |